FDA-cleared K253649

Spectral CT Verida Family

Philips Medical Systems Technologies, Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2026-03-27
FDA-cleared K252421

JLK-NCCT

JLK, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2026-03-24
FDA-cleared K253686

True Definition DL

Ge Healthcare Japan Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2026-03-23
FDA-cleared K253520

Photonova Spectra, Photonova Spectra Select

Ge Medical Systems, LLC

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2026-03-20
FDA-cleared K253574

SOMATOM X.cite; SOMATOM X.ceed

Siemens Medical Solutions USA, Inc.

SOMATOM X.cite and X.ceed with syngo CT VB20 support diagnostic CT, interventions, treatment preparation, radiation-therapy planning, and qualified low-dose lung screening.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2026-03-20
FDA-cleared K253944

Data Analysis Facilitation Suite (DAFS)

Voronoi Health Analytics Incorporated

DAFS automatically segments anatomy on DICOM Part 10 CT images and supports reviewed two- and three-dimensional visualization, editing, and area, volume, and intensity...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2026-03-16
FDA-cleared K260078

Aquilion ServeSP (TSX-307B) V2.0

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2026-03-13
FDA-cleared K260166

Bunkerhill Contrast CAC

BunkerHill Health

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2026-03-06
FDA-cleared K260167

Bunkerhill Contrast AVC

BunkerHill Health

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2026-03-06
FDA-cleared K260169

AV Cardiac CT

Philips Medical Systems Nederland B.V.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2026-03-05
FDA-cleared K253818

Annalise Enterprise

Harrison-AI Medical Pty, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2026-03-03
FDA-cleared K251769

RevealAI-Lung

Precision Medical Ventures, Inc. Dba Revealdx

FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2026-01-30
FDA-cleared K251195

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2026-01-27
FDA-cleared K253173

uCT 780 with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2026-01-20
FDA-cleared K252856

PeekMed web

Peek Health, S.A.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-12-22
FDA-cleared K252029

AI-CVD

HeartLung Corporation

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-12-19
FDA-cleared K251763

IRISeg

Intuitive Surgical, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-12-16
FDA-cleared K251203

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-12-03
FDA-cleared K252217

CT VScore+

Canon Medical Informatics, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-11-28
FDA-cleared K252366

a2z-Unified-Triage

A2z Radiology Ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-11-24
FDA-cleared K252452

PeekMed web

Peek Health, S.A.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-11-12
FDA-cleared K252041

Fibresolve (with PCCP)

Imvaria, Inc.

FDA product code QWO identifies this device class as Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. Radiology software for referral of findings...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-11-07
FDA-cleared K253265

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-11-06
FDA-cleared K250337

AiORTA - Plan

ViTAA Medical Solutions, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-10-30
FDA-cleared K251027

cvi42 Coronary Plaque Software Application

Circle Cardiovascular Imaging, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Heart
Decision
2025-10-27
FDA-cleared K250288

TeraRecon Cardiovascular.Calcification.CT

Terarecon,Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Vascular
Decision
2025-10-23
FDA-cleared K252665

brAIn™ Shoulder Positioning

Avatar Medical

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Brain
Decision
2025-10-20
FDA-cleared K250662

Bunkerhill MAC

Bunkerhill Health

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-10-03
FDA-cleared K250766

LungQ 4

Thirona BV

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-10-02
FDA-cleared K251987

Rapid Aortic Measurements

iSchemaView, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Cardiovascular
Decision
2025-09-23
FDA-cleared K250369

Axial3D Insight

Axial Medical Printing Limited

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-09-18
FDA-cleared K244002

AngioWaveNet

Angiowave Imaging, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Vascular
Decision
2025-09-10
FDA-cleared K251072

Segmentron Viewer

DGNCT, LLC

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-09-09
FDA-cleared K251610

qER-CTA (v1.0)

Qure.ai Technologies

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-09-08
FDA-cleared K251656

Careverse CoronaryDoc (Careverse CoronaryDoc)

Careverse Technology Pte. Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Heart
Decision
2025-09-04
FDA-cleared K243859

PRAEVAorta®2

Nurea

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2025-08-29
FDA-cleared K250290

SurgiTwin

Twinsight

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-08-29
FDA-cleared K251590

Methinks CTA Stroke

Methinks Software S.L.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-08-20
FDA-cleared K251837

Salix Coronary Plaque (V1.0.0)

Artrya Limited

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Heart
Decision
2025-08-20
FDA-cleared K250941

Revolution Vibe

GE Medical Systems, LLC

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-08-01
FDA-cleared K251151

Rapid CTA 360

iSchemaView

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-07-16
FDA-cleared K251096

PeekMed web

Peek Health, S.A.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-07-14
FDA-cleared K243779

Bunkerhill Abdominal Aortic Quantification (AAQ)

BunkerHill Health

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Cardiovascular
Decision
2025-07-01
FDA-cleared K250221

StrokeSENS ASPECTS Software Application

Circle Cardiovascular Imaging Inc.

FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-07-01
FDA-cleared K243672

CardIQ Suite

GE Medical Systems SCS

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-06-18
FDA-cleared K250685

Methinks NCCT Stroke

Methinks Software S.L.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-06-16
FDA-cleared K250354

Viz Subdural+, Viz SUBDURAL PLUS

Viz.ai, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-06-10
FDA-cleared K243810

TraumaCad Neo (1.1)

Brainlab Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-06-04
FDA-cleared K251406

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-05-30
FDA-cleared K243378

Rapid MLS

iSchemaview Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-05-28
FDA-cleared K250005

Clever One

Ewoosoft Co., Ltd

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-05-23
FDA-cleared K250370

SCENARIA View Phase 5.0

FUJIFILM Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-05-20
FDA-cleared K240554

InferRead Lung CT.AI

Infervision Medical Technology Co., Ltd.

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-05-16
FDA-cleared K242624

Medical Image Post-processing Software (uOmnispace.CT)

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-05-14
FDA-cleared K242500

LARALAB

LARALAB GmbH

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-04-16
FDA-cleared K243145

syngo.CT LVO Detection

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-04-10
FDA-cleared K242295

BunkerHill BMD

BunkerHill Health

FDA product code KGI identifies this device class as Densitometer, Bone. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-04-08
FDA-cleared K241984

Hi-D Imaging 4TAVR

Hi-D Imaging AG

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-04-02
FDA-cleared K242166

TribusConnect

TribusMed Beheer BV

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-03-31
FDA-cleared K242919

V5med Lung AI

V5med Inc.

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-03-27
FDA-cleared K243038

Salix Central

Artrya Limited

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-03-27
FDA-cleared K241961

Vent Creativity Knee v1.0 (Hermes)

Vent Creativity

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Knee
Decision
2025-03-20
FDA-cleared K243292

brAIn™ Shoulder Positioning

Avatar Medical

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Brain
Decision
2025-03-20
FDA-cleared K243689

AVIEW

Coreline Soft Co., Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-03-19
FDA-cleared K250042

PeekMed web

Peek Health, S.A.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-03-19
FDA-cleared K242338

Cleerly LABS (v2.0)

Cleerly, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-03-07
FDA-cleared K243611

JLK-SDH

JLK, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-03-03
FDA-cleared K242240

CaRi-Plaque

Caristo Diagnostics Ltd.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-02-20
FDA-cleared K243294

Brainomix 360 e-ASPECTS

Brainomix Limited

FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-02-14
FDA-cleared K243696

AVIEW CAC

Coreline Soft Co., Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2025-02-14
FDA-cleared K250248

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-02-14
FDA-cleared K243229

Bunkerhill AVC

BunkerHill Health

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-01-27
FDA-cleared K243158

TeraRecon Aorta.CT (1.1.0)

TeraRecon, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Cardiovascular
Decision
2025-01-23
FDA-cleared K243350

Rapid Neuro3D

iSchemaView, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Brain
Decision
2025-01-22
FDA-cleared K241166

uCT 550

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-01-14
FDA-cleared K241891

ScreenDx

Imvaria, Inc

FDA product code QWO identifies this device class as Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. Radiology software for referral of findings...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-01-10
FDA-cleared K241079

uCT 780

Shanghai United Imaging Healthcare Co., Ltd.

uCT 780 produces whole-body cross-sectional CT images, including head, neck, cardiac, and vascular imaging, supports protocol-governed low-dose lung cancer screening and...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2025-01-07
FDA-cleared K242123

Brainomix 360 e-CTA

Brainomix Limited

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Brain
Decision
2025-01-06
FDA-cleared K241350

Clarify DL

GE Medical Systems Israel, Functional Imaging

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-01-03
FDA-cleared K243363

JLK-ICH

JLK, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-01-03
FDA-cleared K242403

Aquilion ONE (TSX-308A/3) V1.5

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-12-23
FDA-cleared K242467

IQ-UIP

Imbio, Inc.

FDA product code QWO identifies this device class as Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. Radiology software for referral of findings...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-12-19
FDA-cleared K243548

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-12-11
FDA-cleared K242461

IRISeg

Intuitive Surgical Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-12-10
FDA-cleared K240926

PeekMed web

Peek Health, S.A.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-12-06
FDA-cleared K241543

DrAid™ for Liver Segmentation

VinBrain Joint Stock Company

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Liver
Decision
2024-12-06
FDA-cleared K242188

ClearRead CT CAC

Riverain Technologies, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-12-03
FDA-cleared K242203

BriefCase-Quantification

Aidoc Medical, Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-11-22
FDA-cleared K241719

NeuroICH

Neurocareai Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2024-11-07
FDA-cleared K242837

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-10-18
FDA-cleared K240943

LungVision

BodyVision Medical Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2024-10-01
FDA-cleared K240369

CAC (gated) Algorithm

BunkerHill Health

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-09-27
FDA-cleared K241480

JBS-LVO

JLK, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2024-09-27
FDA-cleared K242292

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2024-09-24
FDA-cleared K240411

uAI Portal

Shanghai United Imaging Intelligence Co., Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-09-06
FDA-cleared K241847

Imbio PHA (4.0.0)

Imbio, Inc

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-30
FDA-cleared K242275

syngo.via MI Workflows; Scenium; syngo MBF

Siemens Medical Solutions USA, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-30
FDA-cleared K242300

MI View&GO

Siemens Medical Solutions USA, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-30
FDA-cleared K241440

HealthCCSng

Nano-X AI Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-19
FDA-cleared K240740

qCT LN Quant

Qure.ai Technologies

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-16
FDA-cleared K233731

CardIQ Suite

GE Medical Systems SCS

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-01
FDA-cleared K233457

RUS

Hutom Inc.

RUS processes CT images for trained professionals using organ and vessel segmentation, pneumoperitoneum estimation, measurements, paths, and two- or three-dimensional...

Modality
CT/CTA
Anatomy
Chest/Abdomen
Decision
2024-07-12
FDA-cleared K241727

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-07-12
FDA-cleared K240353

Hyper Insight - ICH

SK Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2024-07-01
FDA-cleared K240642

SMART Bun-Yo-Matic CT

Disior Ltd

SMART Bun-Yo-Matic CT analyzes CT images of the foot and ankle to provide three-dimensional visualizations, measurements, and surgical-planning information for orthopaedic care.

Modality
CT/CTA
Anatomy
Foot/Ankle
Decision
2024-06-20
FDA-cleared K241038

Cardiac CT Function Software Application

Circle Cardiovascular Imaging

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Heart
Decision
2024-06-07
FDA-cleared K240612

CINA-VCF

Avicenna.AI

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-05-31
FDA-cleared K233209

uOmnispace.CT

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-05-17
FDA-cleared K233247

Heuron ICH

Heuron Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2024-05-15
FDA-cleared K241112

BriefCase-Quantification

Aidoc Medical, Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-05-15
FDA-cleared K232491

CT 5300

Philips Healthcare (Suzhou) Co., Ltd.

CT 5300 acquires head and whole-body cross-sectional CT images for diagnosis in adult and pediatric patients and supports low-dose lung-cancer screening under approved protocols.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2024-05-03
FDA-cleared K233698

True Enhance DL

GE Healthcare Japan Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-04-11
FDA-cleared K240172

Preview Shoulder

Genesis Software Innovations

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Shoulder
Decision
2024-04-04
FDA-cleared K233211

AVIEW CAC

Coreline Soft Co., Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-03-29
FDA-cleared K233657

NAEOTOM Alpha

Siemens Medical Solutions USA, Inc.

NAEOTOM Alpha with syngo CT VB10 provides photon-counting CT for diagnosis, treatment and interventional support, and approved low-dose lung screening; this submission explicitly...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2024-03-28
FDA-cleared K232431

syngo.CT Brain Hemorrhage

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2024-03-22
FDA-cleared K233753

AI-Rad Companion (Pulmonary)

Siemens Healthcare GmbH

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2024-03-21
FDA-cleared K233342

CINA-ASPECTS

Avicenna.AI

FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-03-15
FDA-cleared K233968

CINA-iPE

Avicenna.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-03-13
FDA-cleared K231690

iCAS-LV

HighRAD Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-03-01
FDA-cleared K232613

CT Cardiomegaly

Innolitics, LLC

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-02-28
FDA-cleared K233749

Revolution Ascend Sliding

GE Hangwei Medical Systems Co., Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-02-22
FDA-cleared K233080

HealthFLD

Nano-X AI Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-02-08
FDA-cleared K232363

Viz HDS, Viz Volume Plus, Viz ICH+

Viz.ai, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Brain
Decision
2024-02-05
FDA-cleared K232156

Rapid ASPECTS (v3)

iSchemaView, Inc.

FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-01-19
FDA-cleared K232698

NemoScan

Software Nemotec S.L.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-01-18
FDA-authorized DEN220040

Fibresolve

Imvaria, Inc

FDA product code QWO identifies this device class as Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. Radiology software for referral of findings...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-01-12
FDA-cleared K231324

DASI Dimensions (V1.0)

DASI Simulations

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-01-08
FDA-cleared K232412

LungQ v3.0.0

Thirona BV

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2024-01-08
FDA-cleared K233176

uOmnispace.MI

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-12-20
FDA-cleared K231570

StrokeViewer Perfusion

NICo-Lab B.V.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Brain
Decision
2023-12-14
FDA-cleared K223757

Bonelogic

Disior Ltd

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Bone
Decision
2023-12-08
FDA-cleared K233334

Aquilion Serve SP (TSX-307B/1) V1.3

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-12-06
FDA-cleared K231631

BriefCase-Quantification

Aidoc Medical, Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-11-28
FDA-cleared K232841

Axial3D Insight

Axial Medical Printing Limited

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2023-11-15
FDA-cleared K232083

BriefCase-Quantification

Aidoc Medical, Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2023-11-13
FDA-cleared K230534

BriefCase-Quantification

Aidoc Medical, Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2023-11-08
FDA-cleared K232751

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2023-10-30
FDA-cleared K232045

MeVis Liver Suite

MeVis Medical Solutions AG

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Liver
Decision
2023-10-27
FDA-cleared K232436

Rapid SDH

iSchemaView, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2023-10-25
FDA-cleared K230370

SpotLight/SpotLight Duo (with DLIR option)

Arineta Ltd.

SpotLight and SpotLight Duo are dedicated cardiovascular and thoracic CT systems; K230370 adds optional deep-learning image reconstruction for patients older than 2 years to...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2023-10-13
FDA-cleared K230220

NeuViz 128 Multi-Slice CT Scanner System

Neusoft Medical Systems Co., Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-10-11
FDA-cleared K230045

HipCheck

Stryker Corp.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Hip
Decision
2023-09-29
FDA-cleared K231281

Aquilion Serve (TSX-307A/1) V1.3

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-09-19
FDA-cleared K231157

syngo.CT Lung CAD (Version VD30)

Siemens Healthcare GmbH

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2023-07-19
FDA-cleared K231757

Ez3D-i /E3

Ewoosoft Co., Ltd

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2023-07-14
FDA-cleared K223424

Spine Auto Views

GE Medical Systems SCS

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Spine
Decision
2023-07-13
FDA-cleared K222745

Axial3D Insight

Axial Medical Printing Limited

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2023-07-03
FDA-cleared K230112

CAC Software

Imbio, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-06-13
FDA-cleared K223855

FEops HEARTguideTM, FEops HEARTguideTM ALPACA

FEops nv

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Heart
Decision
2023-06-06
FDA-cleared K212758

Autoplaque

Cedars-Sinai Medical Center: AIM

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-05-19
FDA-cleared K222676

Ceevra Reveal 3

Ceevra, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2023-04-25
FDA-cleared K230223

iCAC Device

Bunkerhill, Inc

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-04-25
FDA-cleared K230807

Deep Learning Image Reconstruction

GE Healthcare Japan Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-04-20
FDA-cleared K213986

CerebralGo Plus

Yukun (Beijing) Technology Co., Ltd

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Brain
Decision
2023-04-13
FDA-cleared K222360

AI-Rad Companion (Cardiovascular)

Siemens Medical Solutions U.S.A.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Vascular
Decision
2023-04-06
FDA-cleared K213272

Formus Hip

Formus Labs, Ltd

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Hip
Decision
2023-03-31
FDA-cleared K223443

Viz AAA

Viz. ai, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
CT/CTA
Anatomy
N/A
Decision
2023-03-17
FDA-cleared K223514

Spectral Bone Marrow

GE Medical Systems, LLC

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Bone
Decision
2023-03-09
FDA-cleared K223726

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-03-07
FDA-cleared K222819

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-03-03
FDA-cleared K222884

Rapid NCCT Stroke

iSchemaView, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2023-03-02
FDA-cleared K221680

Xeleris V Processing and Review System

GE Healthcare

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-03-01
FDA-cleared K221592

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd.

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2023-02-24
FDA-cleared K221564

Brainomix 360 e-ASPECTS

Brainomix Limited

FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...

Modality
CT/CTA
Anatomy
Brain
Decision
2023-02-23
FDA-cleared K223028

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-02-16
FDA-cleared K223396

Rapid RV/LV

iSchema View Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2023-02-01
FDA-cleared K230020

BriefCase

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
CT/CTA
Anatomy
N/A
Decision
2023-02-01
FDA-cleared K222593

TruPlan Computed Tomography (CT) Imaging Software

Circle Cardiovascular Imaging, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-01-18
FDA-cleared K222458

AIBOLIT 3D+

Aibolit Technologies, LLC

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-01-12
FDA-cleared K214036

AVIEW

Coreline Soft Co.,Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2022-12-23
FDA-cleared K223311

Philips CT 3500

Philips Healthcare (Suzhou) Co., Ltd

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-12-22
FDA-cleared K222692

BriefCase

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-12-05
FDA-cleared K221716

CINA

AVICENNA.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-11-22
FDA-cleared K223042

Viz LVO ContaCT

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-10-21
FDA-cleared K222361

AI-Rad Companion (Musculoskeletal)

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Bone
Decision
2022-10-20
FDA-cleared K220709

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-10-07
FDA-cleared K222329

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-09-28
FDA-cleared K220986

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-09-12
FDA-cleared K221456

Rapid ICH

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-09-12
FDA-cleared K221100

Viz RV/LV

Viz.ai, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2022-08-29
FDA-cleared K222277

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-08-26
FDA-cleared K222172

MI View&GO

Siemens Medical Solutions USA, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2022-08-19
FDA-cleared K213713

AI-Rad Companion (Pulmonary)

Siemens Healthcare GmBh

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2022-08-11
FDA-cleared K221432

Customize

3D-Side SA

Customize supports adult total ankle arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, treatment-plan review, and...

Modality
CT/CTA
Anatomy
Foot/Ankle
Decision
2022-08-03
FDA-cleared K213760

ABMD Software

HeartLung Corporation

FDA product code KGI identifies this device class as Densitometer, Bone. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-07-29
FDA-cleared K220961

Deep Learning Image Reconstruction

GE Healthcare Japan Corporation

TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on the Discovery CT750 HD...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2022-07-29
FDA-cleared K220439

Viz SDH

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-07-25
FDA-cleared K221727

syngo.CT Extended Functionality

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-07-13
FDA-cleared K221463

ElucidVivo A.3

Elucid Bioimaging Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-06-17
FDA-cleared K221314

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-06-03
FDA-cleared K221248

Rapid LVO

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-05-31
FDA-cleared K221219

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-05-17
FDA-cleared K221240

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-05-17
FDA-cleared K220590

aPROMISE X

EXINI Diagnostics AB

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-04-29
FDA-cleared K212441

Philips Incisive CT

Philips Healthcare (Suzhou) Co., Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-04-27
FDA-cleared K213886

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-04-26
FDA-cleared K213944

HealthOST

NanoxAI Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-04-22
FDA-cleared K203783

ClariPulmo

ClariPi Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-04-06
FDA-cleared K213721

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-03-21
FDA-cleared K213779

Customize

3D-Side SA

Customize supports adult shoulder arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, case management, and physician approval; it...

Modality
CT/CTA
Anatomy
Shoulder
Decision
2022-03-16
FDA-cleared K213725

CardIQ Suite

GE Medical Systems SCS

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-03-11
FDA-cleared K213319

Viz ANEURYSM, Viz ANX

Viz.ai, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-02-18
FDA-cleared K213999

Deep Learning Image Reconstruction

GE Medical Systems, LLC.

TrueFidelity deep-learning CT reconstruction supports head, whole-body, cardiac, and vascular imaging on specified Revolution CT configurations with release-specific speed and...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2022-02-18
FDA-cleared K213938

Revolution Ascend

GE Healthcare Japan Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-02-04
FDA-cleared K203260

syngo.CT Brain Hemorrhage

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-01-28
FDA-cleared K214019

syngo.CT Extended Functionality

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-01-20
FDA-cleared K210760

Precise Image

Philips Medical Systems Nederland, B.V.

Precise Image is an adult head-and-body CT reconstruction application for selected Philips Incisive CT protocols that uses a convolutional neural network to reduce noise and...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2022-01-14
FDA-cleared K211443

AIBOLIT 3D+

AIbolit Technologies, LLC

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-01-07
FDA-cleared K213096

Al-Rad Companion (Pulmonary)

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-12-06
FDA-cleared K212261

StrokeSENS LVO

Circle Neurovascular Imaging, Inc

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2021-10-14
FDA-cleared K212067

Deep Learning Image Reconstruction

GE Healthcare Japan Corporation

TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution Ascend.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2021-09-17
FDA-cleared K210085

HealthCCSng

Zebra Medical Vision Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-09-15
FDA-cleared K211828

Aquilion Exceed LB

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-09-10
FDA-cleared K211179

InferRead CT Stroke.AI

Infervision Medical Technology Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2021-08-12
FDA-cleared K203448

uCT ATLAS with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-08-11
FDA-cleared K211222

qER-Quant

Qure.ai Technologies

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2021-07-30
FDA-cleared K211655

aPROMISE

EXINI Diagnostics AB

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-07-27
FDA-cleared K212074

ClariCT.AI

ClariPi Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-07-27
FDA-cleared K211788

HALO

Nico.Lab B.V.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2021-07-08
FDA-cleared K203514

Precise Position

Philips Healthcare (Suzhou) Co., Ltd.

Precise Position uses a ceiling-mounted color and depth camera with a convolutional neural network to assist positioning patients aged 16 years and older on Philips Incisive CT by...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2021-06-17
FDA-cleared K202718

Qmenta Care Platform Family

Mint Labs, Inc., d/b/a. QMENTA

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-06-16
FDA-cleared K211459

syngo.via MI WorkFlows, Scenium, syngo MBF

Siemens Medical Solutions USA, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2021-06-10
FDA-cleared K210237

CINA CHEST

Avicenna.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-05-19
FDA-cleared K210556

Preview Shoulder

Genesis Software Innovations

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
Shoulder
Decision
2021-04-21
FDA-cleared K203258

syngo.CT Lung CAD

Siemens Healthcare GmbH

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-03-31
FDA-cleared K210209

Viz ICH

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2021-03-23
FDA-cleared K203256

Imbio RV/LV Software

Imbio, LLC

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2021-03-09
FDA-cleared K203617

MaxFOV 2

GE Medical Systems, LLC.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-03-02
FDA-cleared K202990

NinesMeasure

Nines, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-02-25
FDA-cleared K202212

TruPlan

Circle Cardiovascular Imaging Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-02-19
FDA-cleared K193271

uAI EasyTriage-Rib

Shanghai United Imaging Intelligence Co., Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
CT/CTA
Anatomy
N/A
Decision
2021-01-15
FDA-cleared K201836

Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-01-12
FDA-cleared K202414

BrainInsight

Hyperfine Research, Inc

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Brain
Decision
2021-01-07
FDA-cleared K203508

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2020-12-29
FDA-cleared K203042

Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-12-10
FDA-cleared K200873

HALO

NICo-Lab B.V.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2020-11-20
FDA-cleared K203169

Revolution Ascend

GE Healthcare Japan Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-11-20
FDA-cleared K201195

syngo.via MI Workflows, syngo MBF

Siemens Medical Solutions USA, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2020-11-18
FDA-cleared K193289

FastStroke, CT Perfusion 4D

GE Medical Systems SCS

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-11-12
FDA-cleared K200750

Neuro.Al Algorithm

TeraRecon, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-11-06
FDA-cleared K201710

A View LCS

Coreline Soft Co., Ltd.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-10-16
FDA-cleared K202280

Cleerly Labs v2.0

Cleerly, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-10-02
FDA-cleared K201103

Xeleris V Processing and Review Systems

GE Healthcare

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-09-25
FDA-cleared K200714

AVIEW

Coreline Soft Co., Ltd

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-08-26
FDA-cleared K201020

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2020-08-26
FDA-cleared K200990

VIDAvision

VIDA Diagnostics Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-08-07
FDA-cleared K201310

Accipiolx

MaxQ Al Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2020-08-07
FDA-cleared K192969

Ezra Plexo Software

Ezra AI Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2020-07-10
FDA-cleared K200941

Rapid LVO

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-07-09
FDA-cleared K193073

Deep Recon

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-07-06
FDA-cleared K192880

InferRead Lung CT.AI

Beijing Infervision Technology Co.,Ltd.

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2020-07-02
FDA-cleared K200760

Rapid ASPECTS

iSchemaView Inc.

FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...

Modality
CT/CTA
Anatomy
N/A
Decision
2020-06-26
FDA-cleared K200855

CINA

AVICENNA.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2020-06-24
FDA-cleared K193298

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2020-06-19
FDA-cleared K200921

qER

Qure.ai Technologies

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2020-06-17
FDA-cleared K201034

Syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-05-14
FDA-cleared K192901

HealthVCF

Zebra Medical Vision Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
CT/CTA
Anatomy
N/A
Decision
2020-05-12
FDA-cleared K193351

NinesAI

Nines, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2020-04-21
FDA-cleared K192167

CuraRad-ICH

CuraCloud Corp.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-04-13
FDA-cleared K193087

Rapid ICH

iSchemaView Incorporated

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-03-31
FDA-cleared K193281

Hepatic VCAR

GE Medical Systems SCS

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Liver
Decision
2020-03-20
FDA-cleared K193658

Viz ICH

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-03-18
FDA-cleared K193267

Al-Rad Companion (Musculoskeletal)

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Bone
Decision
2020-03-16
FDA-cleared K193216

syngo.CT Lung CAD

Siemens Medical Solutions, Inc

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2020-03-09
FDA-cleared K191550

Broncholab

Fluidda Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-03-04
FDA-cleared K192962

icobrain-ctp

Icometrix NV

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-02-28
FDA-cleared K192832

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-02-21
FDA-cleared K192956

Auto Positioning

GE Hangwei Medical Systems, Co., Ltd.

Auto Positioning uses 3D patient-position information and the selected CT protocol to suggest scout range, orientation, table height, and collision checks before a...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2020-01-16
FDA-cleared K192383

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2019-12-20
FDA-cleared K192763

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-12-17
FDA-cleared K193170

Deep Learning Image Reconstruction

GE Healthcare Japan Corporation

TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution EVO.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2019-12-13
FDA-cleared K192571

NemoScan

Software Nemotec S.L.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-12-11
FDA-cleared K191026

MEDIP PRO

MEDICALIP Co., Ltd

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-11-07
FDA-cleared K190868

Cleerly Labs

Cleerly Inc

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-11-05
FDA-cleared K192304

SIS Software Version 3.6.0

Surgical Information Sciences, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-09-13
FDA-cleared K183268

AI-Rad Companion (Cardiovascular)

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Vascular
Decision
2019-09-10
FDA-cleared K183271

AI-Rad Companion (Pulmonary)

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2019-07-26
FDA-cleared K182875

DeepCT

Deep01 Limited

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2019-07-10
FDA-cleared K182901

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

Canon Medical Systems Corporation

Aquilion Precision V8.8 is an ultra-high-resolution whole-body CT system; its AiCE deep-convolutional reconstruction is limited in this clearance to abdomen and pelvis...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2019-07-05
FDA-cleared K183460

ClariCT.AI

ClariPI Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-06-13
FDA-cleared K190424

HealthICH

Zebra Medical Vision Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2019-06-13
FDA-cleared K183046

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

Canon Medical Systems Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-06-12
FDA-cleared K190896

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2019-05-31
FDA-cleared K183593

Lung Vision System

Body Vision Medical Ltd.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2019-04-18
FDA-cleared K190072

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2019-04-15
FDA-cleared K183202

Deep Learning Image Reconstruction

GE Medical Systems, LLC.

TrueFidelity deep-learning CT reconstruction produces low, medium, or high-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution CT.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2019-04-12
FDA-cleared K183204

Bone VCAR (BVCAR)

GE Medical Systems SCS

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Bone
Decision
2019-04-08
FDA-cleared K183019

SIS Software version 3.3.0

Surgical Information Sciences, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-03-19
FDA-cleared K182130

iSchemaView RAPID

iSchemaView, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-12-27
FDA-cleared K183012

vascuCAP

Elucid Bioimaging Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-12-21
FDA-cleared K181247

Vitrea CT Brain Perfusion

Vital Images, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Brain
Decision
2018-11-20
FDA-cleared K182177

Accipiolx

MaxQ-Al Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2018-10-26
FDA-cleared K180647

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2018-08-01
FDA-cleared K173444

Quantitative Total Extensible Imaging (QTxI)

AIQ Solutions, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-07-23
FDA-cleared K172983

HealthCCS

Zebra Medical Vision Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-06-13
FDA-cleared K173821

LungQ Software

Thirona Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2018-06-05
FDA-cleared K180161

Viz CTP

Viz.ai, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-04-20
FDA-cleared K173542

Arterys Oncology DL

Arterys Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Vascular
Decision
2018-01-25
FDA-cleared K161322

CT CoPilot

ZEPMED, LLC.

CT CoPilotTM is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain.

Modality
CT/CTA
Anatomy
Brain
Decision
2016-12-07
FDA-cleared K161625

PixelShine

ALGOMEDICA

PixelShine is intended for networking, communication, processing, and enhancement of CT images in DICOM format.

Modality
CT/CTA
Anatomy
N/A
Decision
2016-09-19
FDA-cleared K161201

ClearRead CT

RIVERAIN TECHNOLOGIES, LLC

ClearRead CT provides adjunctive information and is not intended to be used without the o.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2016-09-09
FDA-cleared K141069

Lung Density Analysis

IMBIO LLC

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2014-09-17
FDA-cleared K133649

HEPATIC VCAR

GE MEDICAL SYSTEMS SCS

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Liver
Decision
2014-04-22
FDA-cleared K120161

ALPHAPOINT IMAGING SOFTWARE

RADLOGICS, INC.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2012-04-13