Radiology AI Directory

Directory

Radiology AI tools

Search 1079 FDA-backed radiology AI listings from the cleaned dataset. Pricing and deployment stay marked unknown when not public.

1079 listings
FDA-cleared K153427

Volpara Imaging Software

Matakina Technology LTD

Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2016-01-07
Breast imaging
FDA-cleared K160088

Cydar EV

Cydar Ltd.

Cydar EV provides augmented reality enhanced X-ray fluoroscopy images for use during X-ray guided surgery.

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2016-07-07
Fluoroscopy/Angiography workflow
FDA-cleared K161148

icobrain

Icometrix

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2016-08-09
MRI workflow
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
Chest CT
FDA-cleared K161625

PixelShine

ALGOMEDICA

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

Modality
Mammography/DBT
Anatomy
N/A
Decision
2016-09-19
Breast imaging
FDA-cleared K163138

Clarius Ultrasound System

Clarius Mobile Health Corp.

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3)

Modality
Ultrasound
Anatomy
N/A
Decision
2016-11-30
Ultrasound workflow
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
Quantification and segmentation
FDA-cleared K163013

Quantib Brain 1.2

Quantib BV

Quantib Brain is post-processing analysis software for the GE Advantage Workstation (AW 4.7) and AW Server (AWS 3.2) platforms using Volume Viewer Apps. 12.3 Ext 8 (or higher).

Modality
MRI
Anatomy
Brain
Decision
2017-01-06
Quantification and segmentationNeuro MRI
FDA-cleared K162830

SIS Software

Surgical Information Sciences, Inc.

SIS Software is an application intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion,...

Modality
MRI
Anatomy
N/A
Decision
2017-02-14
MRI workflow
FDA-cleared K170069

AmCAD-UV

AmCad BioMed Corporation

It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for.

Modality
Ultrasound
Anatomy
N/A
Decision
2017-04-26
Ultrasound workflow
FDA-cleared K163622

Lung Vision

BODY VISION MEDICAL LTD.

cations for Use LungVision System Indications for Use: The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2017-05-11
Quantification and segmentationChest CT
FDA-cleared K170172

UNiD Spine Analyzer

MEDICREA INTERNATIONAL

UNiD Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries.

Modality
MRI
Anatomy
Spine
Decision
2017-05-24
MSK and bone
FDA-cleared K170250

SmartTarget

SmartTarget, Ltd.

SmartTarget ,QGLFDWLRQVIRU8VH(Describe) The SmartTarget device is intended as an accessory for image-guided interventional and diagnostic procedures involving the prostate gland,...

Modality
CT/CTA
Anatomy
Prostate
Decision
2017-06-07
Prostate imaging
FDA-cleared K170747

syngo Application Software

Siemens Medical Solutions, USA, Inc.

syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange...

Modality
Ultrasound
Anatomy
N/A
Decision
2017-06-09
Ultrasound workflow
FDA-authorized DEN170022

QuantX

Quantitative Insights, Inc

Computer-aided detection/diagnosis

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
N/A
Decision
2017-07-19
Detection and CADe
FDA-cleared K170981

NeuroQuant

CorTechs Labs, Inc

is a fully automat ed MR imaging post -processing medical device software that provides automatic labeling, visualization and volumetric quantification of brain structures and...

Modality
MRI
Anatomy
Brain
Decision
2017-09-07
Quantification and segmentationNeuro MRI
FDA-cleared K172385

Clarius Ultrasound System

Clarius Mobile Health Corp.

DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS : Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3) BM Color...

Modality
Ultrasound
Anatomy
Abdomen
Decision
2017-09-14
Ultrasound workflow
FDA-cleared K172356

BladderScan Prime PLUS System

Verathon Incorporated

BladderScan PRIME PLUS system Transducer: N/A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N = new indication; P = previously...

Modality
Ultrasound
Anatomy
N/A
Decision
2017-09-15
Ultrasound workflow
FDA-cleared K163623

Quantra

HOLOGIC, INC.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2017-10-20
Breast imaging
FDA-cleared K172803

Infinitt PACS 7.0

Infinitt Healthcare Co.,Ltd.

Infinitt PACS 7.0 device is PACS software capable of viewing and handling DICOM 3.x medical images. The System allows displaying of images and image studies that may not in the...

Modality
Mammography/DBT
Anatomy
N/A
Decision
2017-10-27
Breast imaging
FDA-cleared K171328

cNeuro cMRI

Combinostics Oy

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2018-01-08
MRI workflow
FDA-cleared K173588

Illumeo System

Philips Medical Systems Technologies, Ltd.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2018-01-12
Breast imaging
FDA-cleared K173542

Arterys Oncology DL

Arterys Inc.

Image analysis/processing for Vascular using CT/CTA.

Modality
CT/CTA
Anatomy
Vascular
Decision
2018-01-25
CT/CTA workflow
FDA-cleared K180091

UNiD Spine Analyzer

Medicrea International

Image analysis/processing for Spine using MRI.

Modality
MRI
Anatomy
Spine
Decision
2018-02-08
MSK and bone
FDA-authorized DEN170073

ContaCT

Viz.Al, Inc.

Triage/notification/prioritization

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
N/A
Decision
2018-02-13
Acute triage and notification
FDA-cleared K170540

DM-Density

Densitas, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2018-02-23
Breast imaging
FDA-cleared K173605

iQMR

Medic Vision - Imaging Solutions Ltd

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2018-03-08
MRI workflow
FDA-cleared K173939

Quantib Brain

Quantib BV

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2018-03-09
Neuro MRI
FDA-cleared K180161

Viz CTP

Viz.ai, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-04-20
CT/CTA workflow
FDA-cleared K180599

Venue

GE Medical Systems Ultrasound and Primary Care Diagnostics,

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2018-05-02
Ultrasound workflow
FDA-cleared K173821

LungQ Software

Thirona Corporation

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2018-06-05
Chest CT
FDA-cleared K172983

HealthCCS

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-06-13
CT/CTA workflow
FDA-cleared K173574

DenSeeMammo

Statlife

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2018-06-26
Breast imaging
FDA-cleared K181572

Workflow Box

Mirada Medical Ltd.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2018-07-10
Radiotherapy planning
FDA-cleared K181574

Uscan

EchoNous, Inc.

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2018-07-10
Ultrasound workflow
FDA-cleared K180647

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-08-01
CT/CTA workflow
FDA-cleared K181892

Ziostation2

Ziosoft, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2018-10-09
Breast imaging
FDA-cleared K182034

Arterys MICA

Arterys Inc.

Image analysis/processing for Vascular using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Vascular
Decision
2018-10-17
Breast imaging
FDA-cleared K182177

Accipiolx

MaxQ-Al Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-10-26
CT/CTA workflow
FDA-cleared K181939

icobrain

icometrix NV

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-11-06
CT/CTA workflow
FDA-cleared K181704

Transpara

ScreenPoint Medical BV

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2018-11-21
Breast imaging
FDA-cleared K182336

SubtlePET

Subtle Medical, Inc.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2018-11-30
Nuclear medicine
FDA-cleared K173749

AMRA Profiler

AMRA Medical AB

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2018-12-06
MRI workflow
FDA-cleared K183012

vascuCAP

Elucid Bioimaging Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-12-21
CT/CTA workflow
FDA-cleared K182564

Quantib ND

Quantib BV

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2018-12-27
MRI workflow
FDA-cleared K180867

AmCAD-UO

AmCad BioMed Corporation

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2018-12-28
Ultrasound workflow
FDA-cleared K183133

MRCP+ v1.0

Perspectum Diagnostics Ltd

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-01-09
CT/CTA workflow
FDA-cleared K183231

SIGNA Premier

GE Medical Systems, LLC

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2019-01-18
MRI workflow
FDA-cleared K183285

cmTriage

CureMetrix, Inc

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2019-03-08
Breast imaging
FDA-cleared K183204

Bone VCAR (BVCAR)

GE Medical Systems SCS

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2019-04-08
MSK and bone
FDA-cleared K190072

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-04-15
CT/CTA workflow
FDA-cleared K190764

SurgicalAR

MEDIVIS, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2019-05-13
Breast imaging
FDA-cleared K190896

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-05-31
CT/CTA workflow
FDA-cleared K183460

ClariCT.AI

ClariPI Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2019-06-13
Breast imaging
FDA-cleared K190424

HealthICH

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-06-13
CT/CTA workflow
FDA-cleared K190387

RayStation

RaySearch Laboratories AB (publ)

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2019-06-19
Radiotherapy planning
FDA-cleared K190442

Koios DS for Breast

Koios Medical, Inc.

Image analysis/processing for Breast using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2019-07-03
Breast imaging
FDA-cleared K191384

RayCare 2.3

RaySearch Laboratories AB (publ)

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2019-07-08
Radiotherapy planning
FDA-cleared K182875

DeepCT

Deep01 Limited

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-07-10
CT/CTA workflow
FDA-cleared K183271

AI-Rad Companion (Pulmonary)

Siemens Medical Solutions USA, Inc.

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2019-07-26
Chest CT
FDA-cleared K191262

aBSI

EXINI Diagnostics AB

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-08-05
CT/CTA workflow
FDA-cleared K183489

D2P

3D Systems, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-08-29
CT/CTA workflow
FDA-cleared K191688

SubtleMR

Subtle Medical, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2019-09-16
MRI workflow
FDA-cleared K192455

Merge PACS

Merge Healthcare Incorporated

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2019-10-17
Breast imaging
FDA-cleared K190868

Cleerly Labs

Cleerly Inc

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-11-05
CT/CTA workflow
FDA-cleared K192109

KOALA

IB Lab GmbH

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-11-05
CT/CTA workflow
FDA-cleared K191026

MEDIP PRO

MEDICALIP Co., Ltd

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-11-07
CT/CTA workflow
FDA-cleared K191278

RSI-MRI+

MultiModal Imaging Services Corporation (dba HealthLytix)

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2019-11-19
MRI workflow
FDA-cleared K192320

HealthCXR

Zebra Medical Vision, Ltd.

Image analysis/processing for Chest/Lung using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2019-11-26
X-ray/Radiography workflow
FDA-cleared K192287

Transpara

Screenpoint Medical B.V.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2019-12-10
Breast imaging
FDA-cleared K192571

NemoScan

Software Nemotec S.L.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-12-11
CT/CTA workflow
FDA-cleared K192130

Icobrain

Icometrix NV

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-12-13
CT/CTA workflow
FDA-cleared K192763

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-12-17
CT/CTA workflow
FDA-cleared K192383

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-12-20
CT/CTA workflow
FDA-cleared K191125

ADAS 3D

Galgo Medical S.L

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-01-15
CT/CTA workflow
FDA-cleared K192956

Auto Positioning

GE Hangwei Medical Systems, Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-01-16
CT/CTA workflow
FDA-cleared K193109

MRCAT brain

Philips Medical Systems MR Finland

Image analysis/processing for Brain using Radiotherapy planning imaging.

Modality
Radiotherapy planning imaging
Anatomy
Brain
Decision
2020-01-24
Radiotherapy planning
FDA-cleared K193178

Biograph Horizon

Siemens Medical Solution USA, Inc.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2020-02-12
Nuclear medicine
FDA-cleared K191556

Red Dot

Behold.AI Technologies Limited

Image analysis/processing.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2020-02-28
X-ray/Radiography workflow
FDA-cleared K191928

AccuContour

Xiamen Manteia Technology LTD.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2020-02-28
Radiotherapy planning
FDA-cleared K192962

icobrain-ctp

Icometrix NV

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-02-28
CT/CTA workflow
FDA-cleared K191550

Broncholab

Fluidda Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-03-04
CT/CTA workflow
FDA-cleared K193229

Transpara

ScreenPoint Medical B.V.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2020-03-05
Breast imaging
FDA-cleared K193216

syngo.CT Lung CAD

Siemens Medical Solutions, Inc

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2020-03-09
Chest CT
FDA-cleared K193658

Viz ICH

Viz.ai, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-03-18
CT/CTA workflow
FDA-cleared K193281

Hepatic VCAR

GE Medical Systems SCS

Image analysis/processing for Liver using CT/CTA.

Modality
CT/CTA
Anatomy
Liver
Decision
2020-03-20
Oncology quantification
FDA-cleared K192437

Arterys MICA

Arterys Inc.

Image analysis/processing for Vascular using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Vascular
Decision
2020-03-25
Breast imaging
FDA-cleared K192854

MammoScreen

Therapixel

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2020-03-25
Breast imaging
FDA-cleared K193518

KOSMOS

EchoNous, Inc.

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2020-03-26
Ultrasound workflow
FDA-cleared K193087

Rapid ICH

iSchemaView Incorporated

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-03-31
CT/CTA workflow
FDA-cleared K193282

SIGNA Premier

GE Healthcare (GE Medical Systems, LLC)

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2020-04-10
MRI workflow
FDA-cleared K192167

CuraRad-ICH

CuraCloud Corp.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-04-13
CT/CTA workflow
FDA-cleared K193351

NinesAI

Nines, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-04-21
CT/CTA workflow
FDA-cleared K193176

uMR 780

Shanghai United Imaging Healthcare Co., Ltd

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2020-05-05
MRI workflow
FDA-cleared K193220

AVIEW LCS

Coreline Soft Co., Ltd

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2020-05-05
Breast imaging
FDA-cleared K192901

HealthVCF

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-05-12
CT/CTA workflow
FDA-cleared K201034

Syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-05-14
CT/CTA workflow
FDA-cleared K192601

uWS-MR

Shanghai United Imaging Healthcare Co., Ltd

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2020-06-01
MRI workflow
FDA-cleared K193290

AI-Rad Companion Brain MR

Siemens Medical Solutions USA, Inc.

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2020-06-17
Neuro MRI
FDA-cleared K200921

qER

Qure.ai Technologies

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-06-17
CT/CTA workflow
FDA-cleared K193298

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-06-19
CT/CTA workflow
FDA-cleared K200855

CINA

AVICENNA.AI

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-06-24
CT/CTA workflow
FDA-cleared K200760

Rapid ASPECTS

iSchemaView Inc.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2020-06-26
Nuclear medicine
FDA-cleared K192880

InferRead Lung CT.AI

Beijing Infervision Technology Co.,Ltd.

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2020-07-02
Chest CT
FDA-cleared K193073

Deep Recon

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-07-06
CT/CTA workflow
FDA-cleared K200941

Rapid LVO

iSchemaView Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-07-09
CT/CTA workflow
FDA-cleared K200905

HealthMammo

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2020-07-16
Breast imaging
FDA-cleared K193210

HYPER DLR

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2020-08-04
Nuclear medicine
FDA-cleared K200990

VIDAvision

VIDA Diagnostics Inc.

Image analysis/processing.

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

Accipiolx

MaxQ Al Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-08-07
CT/CTA workflow
FDA-cleared K201632

TOMTEC-ARENA

TOMTEC Imaging Systems GmbH

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2020-08-14
Breast imaging
FDA-cleared K200714

AVIEW

Coreline Soft Co., Ltd

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2020-08-26
Breast imaging
FDA-cleared K201020

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-08-26
CT/CTA workflow
FDA-cleared K202238

SIGNA Artist

GE Healthcare (Tianjin) Company Limited

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2020-09-04
MRI workflow
FDA-cleared K200708

Vivid iq

GE Medical Systems Ultrasound and

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2020-09-09
Ultrasound workflow
FDA-cleared K200851

Vivid T8, Vivid T9

GE Medical Systems Ultrasound and Primary Care Diagnostics

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2020-09-09
Ultrasound workflow
FDA-cleared K200569

RayStation

RaySearch Laboratories AB (publ)

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2020-09-24
Radiotherapy planning
FDA-cleared K192051

THINQ

CorticoMetrics LLC

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2020-09-30
MRI workflow
FDA-cleared K202501

Quantib Prostate

Quantib BV

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2020-10-11
Prostate imaging
FDA-cleared K201615

SIGNA 7.0T

GE Medical Systems, LLC

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2020-10-15
MRI workflow
FDA-cleared K201710

A View LCS

Coreline Soft Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-10-16
CT/CTA workflow
FDA-cleared K200323

AutoContour

Radformation, Inc.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2020-10-30
Radiotherapy planning
FDA-cleared K193306

PROView

GE Medical Systems SCS

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2020-11-17
MRI workflow
FDA-cleared K193287

CorInsights MRI

ADM Diagnostics, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2020-11-20
MRI workflow
FDA-cleared K200873

HALO

NICo-Lab B.V.

Image analysis/processing.

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

Revolution Ascend

GE Healthcare Japan Corporation

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-11-20
CT/CTA workflow
FDA-cleared K202487

HealthJOINT

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-12-04
CT/CTA workflow
FDA-cleared K201039

HepaFat-AI

Resonance Health Analysis Services Pty Ltd

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2020-12-07
MRI workflow
FDA-cleared K201555

EchoGo Pro

Ultromics Ltd

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2020-12-18
Ultrasound workflow
FDA-cleared K202229

AI Metrics

AI Metrics, LLC

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2020-12-22
Breast imaging
FDA-cleared K203508

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-12-29
CT/CTA workflow
FDA-cleared K202414

BrainInsight

Hyperfine Research, Inc

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-01-07
CT/CTA workflow
FDA-cleared K202700

ART-Plan

TheraPanacea

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2021-01-14
Radiotherapy planning
FDA-cleared K193271

uAI EasyTriage-Rib

Shanghai United Imaging Intelligence Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-01-15
CT/CTA workflow
FDA-cleared K201411

Visage Breast Density

Visage Imaging GmbH

Image analysis/processing for Breast using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2021-01-29
Breast imaging
FDA-cleared K202212

TruPlan

Circle Cardiovascular Imaging Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-02-19
CT/CTA workflow
FDA-cleared K202990

NinesMeasure

Nines, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-02-25
CT/CTA workflow
FDA-cleared K203182

SubtleMR

Subtle Medical, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2021-02-26
MRI workflow
FDA-cleared K203617

MaxFOV 2

GE Medical Systems, LLC.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-03-02
CT/CTA workflow
FDA-cleared K202284

Oncospace

Oncospace, Inc.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2021-03-12
Radiotherapy planning
FDA-cleared K203235

VBrain

Vysioneer Inc.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2021-03-19
Radiotherapy planning
FDA-cleared K210209

Viz ICH

Viz.ai, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2021-03-23
CT/CTA workflow
FDA-cleared K203258

syngo.CT Lung CAD

Siemens Healthcare GmbH

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-03-31
Chest CT
FDA-cleared K202928

DV. Target

Deepvoxel INC

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2021-04-02
Radiotherapy planning
FDA-cleared K203517

Saige-Q

DeepHealth, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2021-04-16
Breast imaging
FDA-cleared K203469

AI Segmentation

Varian Medical Systems, Inc.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2021-04-19
Radiotherapy planning
FDA-cleared K210556

Preview Shoulder

Genesis Software Innovations

Image analysis/processing for Shoulder using CT/CTA.

Modality
CT/CTA
Anatomy
Shoulder
Decision
2021-04-21
CT/CTA workflow
FDA-cleared K210001

HYPER AiR

Shanghai United Imaging Healthcare Co.,Ltd.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2021-04-30
Nuclear medicine
FDA-cleared K211118

SIGNA 7.0T

GE Medical Systems, LLC

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2021-05-13
MRI workflow
FDA-cleared K210187

Overjet Dental Assist

Overjet, Inc.

Image analysis/processing for Dental/Maxillofacial using MRI.

Modality
MRI
Anatomy
Dental/Maxillofacial
Decision
2021-05-19
MRI workflow
FDA-cleared K210237

CINA CHEST

Avicenna.AI

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-05-19
Chest CT
FDA-cleared K210404

Transpara 1.7.0

ScreenPoint Medical B.V.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2021-06-02
Breast imaging
FDA-cleared K203514

Precise Position

Philips Healthcare (Suzhou) Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-06-17
CT/CTA workflow
FDA-cleared K210645

RayStation 10.1

RaySearch Laboratories AB (publ)

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2021-06-29
Radiotherapy planning
FDA-cleared K210611

MAGNETOM Free.Max

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2021-07-01
MRI workflow
FDA-cleared K210666

Chest-CAD

Imagen Technologies, Inc

Image analysis/processing for Chest/Lung using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2021-07-20
X-ray/Radiography workflow
FDA-cleared K210791

Us2.v1

eko.ai Pte. Ltd. d/b/a Us2.ai

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2021-07-27
Ultrasound workflow
FDA-cleared K211655

aPROMISE

EXINI Diagnostics AB

Image analysis/processing.

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

ClariCT.AI

ClariPi Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-07-27
CT/CTA workflow
FDA-cleared K211222

qER-Quant

Qure.ai Technologies

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-07-30
CT/CTA workflow
FDA-cleared K211431

breastscape v1.0

Olea Medical

Image analysis/processing for Breast using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2021-08-02
Breast imaging
FDA-cleared K211764

Vereos PET/CT

Philips Medical Systems Nederland B.V.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2021-08-06
Nuclear medicine
FDA-cleared K212100

Kosmos

EchoNous, Inc.

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2021-08-06
Ultrasound workflow
FDA-cleared K211179

InferRead CT Stroke.AI

Infervision Medical Technology Co., Ltd.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2021-08-12
CT/CTA workflow
FDA-cleared K211846

Discovery MI Gen2

GE Medical Systems, LLC.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2021-08-20
Nuclear medicine
FDA-cleared K203696

RBknee

Radiobotics ApS

Indications for Use statement. Please note that the 510(k) submission was not re-reviewed.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2021-08-27
X-ray/Radiography workflow
FDA-cleared K211881

AI Segmentation

Varian Medical Systems, Inc.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2021-09-02
Radiotherapy planning
FDA-cleared K203555

AmCAD-UT

AmCad BioMed Corporation

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2021-09-08
Ultrasound workflow
FDA-cleared K211867

RayStation 11.0

RaySearch Laboratories AB (publ)

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2021-09-08
Radiotherapy planning
FDA-cleared K203785

ClariSIGMAM

ClariPi Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2021-09-10
Breast imaging
FDA-cleared K210438

Versana Premier

GE Medical Systems Ultrasound and Primary Care Diagnostics,

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2021-09-10
Ultrasound workflow
FDA-cleared K211828

Aquilion Exceed LB

Canon Medical Systems Corporation

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-09-10
CT/CTA workflow
FDA-cleared K210085

HealthCCSng

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-09-15
CT/CTA workflow
FDA-cleared K211964

SubtlePET

Subtle Medical, Inc.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2021-09-28
Nuclear medicine
FDA-cleared K212116

VBrain-OAR

Vysioneer Inc.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2021-10-12
Radiotherapy planning
FDA-cleared K210999

SwiftMR

AIRS Medical Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2021-10-14
MRI workflow
FDA-cleared K212261

StrokeSENS LVO

Circle Neurovascular Imaging, Inc

Image analysis/processing for Brain using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Brain
Decision
2021-10-14
Breast imaging
FDA-cleared K210831

OnQ Neuro

CorTechs Labs, Inc

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-11-19
CT/CTA workflow
FDA-cleared K211541

MammoScreen 2.0

Therapixel

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2021-11-26
Breast imaging
FDA-cleared K213096

Al-Rad Companion (Pulmonary)

Siemens Medical Solutions USA, Inc.

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-12-06
Chest CT
FDA-cleared K213155

RT-Mind-AI

MedMind Technology Co., Ltd.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2021-12-15
Radiotherapy planning
FDA-cleared K212616

Koios DS

Koios Medical, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2021-12-16
Breast imaging
FDA-cleared K213628

VBrain

Vysioneer Inc.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2021-12-16
Radiotherapy planning
FDA-cleared K210670

BU-CAD

TaiHao Medical Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2021-12-21
Breast imaging
FDA-cleared K212690

qXR-BT

Qure.ai Technologies

Image analysis/processing.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2021-12-21
X-ray/Radiography workflow
FDA-cleared K202404

BoneMRI

MRIguidance B.V

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2021-12-22
MSK and bone
FDA-cleared K213776

LiverSmart

Resonance Health Analysis Services Pty Ltd

Image analysis/processing for Liver using PET/SPECT/Nuclear Medicine.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Liver
Decision
2021-12-29
Oncology quantificationNuclear medicine
FDA-cleared K213544

TOMTEC-ARENA

TOMTEC Imaging Systems GmbH

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2022-01-06
Breast imaging
FDA-cleared K211443

AIBOLIT 3D+

AIbolit Technologies, LLC

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-01-07
CT/CTA workflow
FDA-cleared K212005

UNiD Spine Analyzer

MEDICREA International, Inc.

Image analysis/processing for Spine using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2022-01-12
MSK and bone
FDA-cleared K210760

Precise Image

Philips Medical Systems Nederland, B.V.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-01-14
CT/CTA workflow
FDA-cleared K213737

Quantib ND

Quantib B.V.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-01-14
MRI workflow
FDA-cleared K211980

SIGNA Prime

GE Healthcare (Tianjin) Company Limited

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-01-16
MRI workflow
FDA-cleared K213668

SIGNA Hero

GE Healthcare (GE Medical Systems, LLC)

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-01-20
MRI workflow
FDA-cleared K213938

Revolution Ascend

GE Healthcare Japan Corporation

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-02-04
CT/CTA workflow
FDA-cleared K213165

Rapid

iSchema View Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-02-08
CT/CTA workflow
FDA-cleared K213603

SIGNA Artist Evo

GE Healthcare(Tianjin) Company Limited

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-02-11
MRI workflow
FDA-cleared K212365

BoneView

Gleamer

Image analysis/processing for Bone using PET/SPECT/Nuclear Medicine.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Bone
Decision
2022-03-01
MSK and boneNuclear medicine
FDA-cleared K210365

Second Opinion

Pearl Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-03-04
MRI workflow
FDA-cleared K213725

CardIQ Suite

GE Medical Systems SCS

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-03-11
CT/CTA workflow
FDA-cleared K203744

Arterys MICA

Arterys Inc.

Image analysis/processing for Vascular using CT/CTA.

Modality
CT/CTA
Anatomy
Vascular
Decision
2022-03-14
CT/CTA workflow
FDA-cleared K214043

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-03-14
CT/CTA workflow
FDA-cleared K213779

Customize

3D-Side SA

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-03-16
CT/CTA workflow
FDA-cleared K213721

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-03-21
CT/CTA workflow
FDA-cleared K220151

MAGNETOM Avanto Fit

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-04-01
MRI workflow
FDA-cleared K214081

MRCAT Head & Neck

Philips Oy

Image analysis/processing for Head/Neck using Radiotherapy planning imaging.

Modality
Radiotherapy planning imaging
Anatomy
Head/Neck
Decision
2022-04-05
Radiotherapy planning
FDA-cleared K203783

ClariPulmo

ClariPi Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-04-06
CT/CTA workflow
FDA-cleared K212274

INT Contour

Carina Medical LLC

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2022-04-08
Radiotherapy planning
FDA-cleared K213706

AI-Rad Companion Brain MR

Siemens Healthcare GmBh

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2022-04-15
Neuro MRI
FDA-cleared K220141

RayStation 11B

RaySearch Laboratories AB (publ)

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2022-04-15
Radiotherapy planning
FDA-cleared K213944

HealthOST

NanoxAI Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-04-22
CT/CTA workflow
FDA-cleared K213886

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2022-04-26
Breast imaging
FDA-cleared K212441

Philips Incisive CT

Philips Healthcare (Suzhou) Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-04-27
CT/CTA workflow
FDA-cleared K220590

aPROMISE X

EXINI Diagnostics AB

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-04-29
CT/CTA workflow
FDA-cleared K220446

Versana Balance

GE Medical Systems Ultrasound and Primary Care Diagnostics,

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2022-05-11
Ultrasound workflow
FDA-cleared K220105

Saige-Dx

DeepHealth, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2022-05-12
Breast imaging
FDA-cleared K220589

MAGNETOM Skyra Fit

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-05-13
MRI workflow
FDA-cleared K221106

Quantib Prostate

Quantib BV

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2022-05-13
Prostate imaging
FDA-cleared K221219

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

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

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-05-17
CT/CTA workflow
FDA-cleared K220416

SwiftMR

AIRS Medical Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-05-25
MRI workflow
FDA-cleared K221248

Rapid LVO

iSchemaView Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2022-05-31
CT/CTA workflow
FDA-cleared K220164

Rayvolve

AZmed SAS

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2022-06-02
Nuclear medicine
FDA-cleared K221314

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-06-03
CT/CTA workflow
FDA-cleared K213717

AIR Recon DL

GE Medical Systems,LLC (GE Healthcare)

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-06-08
MRI workflow
FDA-cleared K220813

ART-PLAN

TheraPanacea

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2022-06-17
Radiotherapy planning
FDA-cleared K221463

ElucidVivo A.3

Elucid Bioimaging Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-06-17
CT/CTA workflow
FDA-cleared K220800

Venue Go

GE Medical Systems Ultrasound and Primary Care Diagnostics

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2022-06-21
Ultrasound workflow
FDA-cleared K220497

CoLumbo

Smart Soft Healthcare AD

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-06-23
CT/CTA workflow
FDA-cleared K220848

Venue Fit

GE Medical Systems

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2022-06-27
Ultrasound workflow
FDA-cleared K220851

Venue

GE Medical Systems

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2022-06-27
Ultrasound workflow
FDA-cleared K212783

ProstatID

ScanMed, LLC

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2022-07-08
Breast imaging
FDA-cleared K221147

Vivid T8, Vivid T9

GE Medical Systems Ultrasound and Primary Care Diagnostics,

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2022-07-18
Ultrasound workflow
FDA-cleared K221148

Vivid iq

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2022-07-18
Ultrasound workflow
FDA-cleared K220815

BrainInsight

Hyperfine, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-07-19
CT/CTA workflow
FDA-cleared K220624

AI4CMR v1.0

AI4MedImaging Medical Solutions S.A.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-07-22
CT/CTA workflow
FDA-cleared K220439

Viz SDH

Viz.ai, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-07-25
CT/CTA workflow
FDA-cleared K213760

ABMD Software

HeartLung Corporation

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-07-29
CT/CTA workflow
FDA-cleared K221347

Transpara 1.7.2

ScreenPoint Medical B.V.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2022-08-03
Breast imaging
FDA-cleared K221432

Customize

3D-Side SA

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-08-03
CT/CTA workflow
FDA-cleared K213713

AI-Rad Companion (Pulmonary)

Siemens Healthcare GmBh

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2022-08-11
Chest CT
FDA-cleared K222172

MI View&GO

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-08-19
CT/CTA workflow
FDA-cleared K211841

MRI Planner

Spectronic Medical AB

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2022-08-25
Radiotherapy planning
FDA-cleared K222277

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-08-26
CT/CTA workflow
FDA-cleared K221100

Viz RV/LV

Viz.ai, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-08-29
CT/CTA workflow
FDA-cleared K221456

Rapid ICH

iSchemaView Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2022-09-12
CT/CTA workflow
FDA-cleared K213353

Aorta-CAD

Imagen Technologies, Inc

Image analysis/processing for Cardiovascular using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Cardiovascular
Decision
2022-09-20
X-ray/Radiography workflow
FDA-cleared K221738

NS-HGlio

Neosoma Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-09-27
MRI workflow
FDA-cleared K222329

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-09-28
CT/CTA workflow
FDA-cleared K220080

CogNet QmTRIAGE

MedCognetics, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2022-09-29
Breast imaging
FDA-cleared K211611

QIR Suite

CASIS Cardiac Simulation & Imaging Software

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-09-30
CT/CTA workflow
FDA-cleared K220709

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-10-07
CT/CTA workflow
FDA-cleared K221632

Spine CAMP™

Medical Metrics, Inc.

Image analysis/processing for Spine using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2022-10-18
MSK and bone
FDA-cleared K223042

Viz LVO ContaCT

Viz.ai, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2022-10-21
CT/CTA workflow
FDA-cleared K220408

AVIEW RT ACS

Coreline Soft Co.,Ltd

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2022-11-10
Radiotherapy planning
FDA-cleared K221762

BoneMRI v1.4

MRlguidance B.V.

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2022-11-16
MSK and bone
FDA-cleared K221330

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-11-18
CT/CTA workflow
FDA-cleared K221716

CINA

AVICENNA.AI

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-11-22
CT/CTA workflow
FDA-cleared K222692

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-12-05
CT/CTA workflow
FDA-cleared K222275

Saige-Density

DeepHealth, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2022-12-16
Breast imaging
FDA-cleared K223268

BrainInsight

Hyperfine, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-12-16
CT/CTA workflow
FDA-cleared K223311

Philips CT 3500

Philips Healthcare (Suzhou) Co., Ltd

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-12-22
CT/CTA workflow
FDA-cleared K214036

AVIEW

Coreline Soft Co.,Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-12-23
CT/CTA workflow
FDA-cleared K222458

AIBOLIT 3D+

Aibolit Technologies, LLC

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-01-12
CT/CTA workflow
FDA-cleared K222406

Clarius AI

Clarius Mobile Health Corp.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-01-23
CT/CTA workflow
FDA-cleared K222970

LVivo IQS

DiA Imaging Analysis Ltd

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2023-02-01
Ultrasound workflow
FDA-cleared K223396

Rapid RV/LV

iSchema View Inc.

Image analysis/processing.

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

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-02-01
CT/CTA workflow
FDA-cleared K222803

Oncospace

Oncospace, Inc.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2023-02-02
Radiotherapy planning
FDA-cleared K223439

SIGNA Victor

GE Healthcare (Tianjin) Company Limited

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-02-13
MRI workflow
FDA-cleared K222755

uMR 680

Shanghai United Imaging Intelligence Co., Ltd.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-02-16
MRI workflow
FDA-cleared K230197

BoneMRI v1.6

MRIguidance B.V.

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2023-02-22
MSK and bone
FDA-cleared K221592

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd.

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2023-02-24
Chest CT
FDA-cleared K222176

BoneView

Gleamer

Image analysis/processing for Bone using PET/SPECT/Nuclear Medicine.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Bone
Decision
2023-03-02
MSK and boneNuclear medicine
FDA-cleared K222884

Rapid NCCT Stroke

iSchemaView, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2023-03-02
CT/CTA workflow
FDA-cleared K221706

AccuContour

Manteia Technologies Co., Ltd.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2023-03-09
Radiotherapy planning
FDA-cleared K223514

Spectral Bone Marrow

GE Medical Systems, LLC

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2023-03-09
MSK and bone
FDA-cleared K223325

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2023-03-10
Nuclear medicine
FDA-cleared K223443

Viz AAA

Viz. ai, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-03-17
CT/CTA workflow
FDA-cleared K222174

RadioLens v1.0

Synapsica

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2023-03-28
Breast imaging
FDA-cleared K222312

RayStation 12A

RaySearch Laboratories AB (publ)

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2023-03-29
Radiotherapy planning
FDA-cleared K213272

Formus Hip

Formus Labs, Ltd

Image analysis/processing for Hip using CT/CTA.

Modality
CT/CTA
Anatomy
Hip
Decision
2023-03-31
CT/CTA workflow
FDA-cleared K213986

CerebralGo Plus

Yukun (Beijing) Technology Co., Ltd

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2023-04-13
CT/CTA workflow
FDA-cleared K230264

Ezra Flash

Ezra AI, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-04-13
MRI workflow
FDA-cleared K230772

Quantib Prostate

Quantib BV

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2023-04-17
Prostate imaging
FDA-cleared K230023

ART-Plan

Therapanacea SAS

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2023-04-19
Radiotherapy planning
FDA-cleared K223287

Velacur

Sonic Incytes

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2023-04-20
Ultrasound workflow
FDA-cleared K230223

iCAC Device

Bunkerhill, Inc

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-04-25
CT/CTA workflow
FDA-cleared K223212

Precision DL

GE Healthcare

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2023-04-27
Nuclear medicine
FDA-cleared K230977

SIS System

Surgical Information Sciences, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-05-02
CT/CTA workflow
FDA-cleared K220437

Neurophet AQUA

NEUROPHET, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-05-10
MRI workflow
FDA-cleared K223623

SubtleMR (2.3.x)

Subtle Medical Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-05-11
MRI workflow
FDA-cleared K212758

Autoplaque

Cedars-Sinai Medical Center: AIM

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-05-19
CT/CTA workflow
FDA-cleared K223523

Sonic DL

GE Medical Systems,LLC (GE Healthcare)

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-05-30
MRI workflow
FDA-cleared K230112

CAC Software

Imbio, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-06-13
CT/CTA workflow
FDA-cleared K223556

DeepCatch

MEDICALIP Co., Ltd

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2023-06-16
Breast imaging
FDA-cleared K231459

HepaFatSmart (V2.0.0)

Resonance Health Analysis Services Pty Ltd

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-06-20
MRI workflow
FDA-cleared K222745

Axial3D Insight

Axial Medical Printing Limited

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-07-03
CT/CTA workflow
FDA-cleared K231668

Spine CAMP™ (1.1)

Medical Metrics, Inc.

Image analysis/processing for Spine using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2023-07-07
MSK and bone
FDA-cleared K223724

MOZI TPS

Manteia Technologies Co., Ltd.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2023-07-10
Radiotherapy planning
FDA-cleared K223424

Spine Auto Views

GE Medical Systems SCS

Image analysis/processing for Spine using CT/CTA.

Modality
CT/CTA
Anatomy
Spine
Decision
2023-07-13
MSK and bone
FDA-cleared K231757

Ez3D-i /E3

Ewoosoft Co., Ltd

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-07-14
CT/CTA workflow
FDA-cleared K230039

uOmnispace

Shanghai United Imaging Healthcare Co., Ltd

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2023-07-20
Breast imaging
FDA-cleared K230150

OptimMRI

RebrAIn, SAS

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-07-21
MRI workflow
FDA-cleared K230913

ANDI

Imeka Solutions, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-07-25
MRI workflow
FDA-cleared K231572

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2023-07-26
Nuclear medicine
FDA-cleared K223180

AIRAscore

AIRAmed GmbH

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-08-25
CT/CTA workflow
FDA-cleared K223621

DeepXray

Alpha Intelligence Manifolds, Inc.

Image analysis/processing.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-09-08
X-ray/Radiography workflow
FDA-cleared K223811

Lung-CAD

Imagen Technologies, Inc

Image analysis/processing for Chest/Lung using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2023-09-13
X-ray/Radiography workflow
FDA-cleared K220034

NEUROShield

In-Med Prognostics L3C

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-09-14
MRI workflow
FDA-cleared K223659

Jazz

AI Medical AG

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-09-22
MRI workflow
FDA-cleared K230045

HipCheck

Stryker Corp.

Image analysis/processing for Hip using CT/CTA.

Modality
CT/CTA
Anatomy
Hip
Decision
2023-09-29
CT/CTA workflow
FDA-cleared K230085

Lung-CAD

Imagen Technologies, Inc

Image analysis/processing for Chest/Lung using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2023-10-03
X-ray/Radiography workflow
FDA-cleared K232712

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2023-10-03
Nuclear medicine
FDA-cleared K232023

Momentum Spine

Momentum Health Inc.

Image analysis/processing for Spine using Radiotherapy planning imaging.

Modality
Radiotherapy planning imaging
Anatomy
Spine
Decision
2023-10-04
Radiotherapy planningMSK and bone
FDA-cleared K232367

cmAngio® V1.0

CureMetrix, Inc.

Image analysis/processing for Vascular using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Vascular
Decision
2023-10-05
Breast imaging
FDA-cleared K231642

Veuron-Brain-pAb3

Heuron Co., Ltd.

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2023-10-13
Neuro MRI
FDA-cleared K230209

Sonix Health

Ontact Health Co., Ltd.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2023-10-20
Breast imaging
FDA-cleared K232305

AI-Rad Companion Brain MR

Siemens Medical Solutions U.S.A.

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2023-10-23
Neuro MRI
FDA-cleared K232436

Rapid SDH

iSchemaView, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-10-25
CT/CTA workflow
FDA-cleared K230854

SwiftMR

AIRS Medical Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-10-27
MRI workflow
FDA-cleared K231470

Lunit INSIGHT DBT

Lunit Inc.

Image analysis/processing for Breast using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2023-11-06
Breast imaging
FDA-cleared K231966

LOGIQ E10

GE Medical Systems Ultrasound and Primary care Diagnostics,

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2023-11-07
Ultrasound workflow
FDA-cleared K232841

Axial3D Insight

Axial Medical Printing Limited

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-11-15
CT/CTA workflow
FDA-cleared K232381

LOGIQ Totus

GE Medical Systems Ultrasound and Primary care Diagnostics,

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2023-12-07
Ultrasound workflow
FDA-cleared K223757

Bonelogic

Disior Ltd

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2023-12-08
MSK and bone
FDA-cleared K232231

QP-Brain®

Quibim S.L.

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2023-12-13
Neuro MRI
FDA-cleared K232384

Videa Dental Assist

VideaHealth, Inc.

Image analysis/processing for Dental/Maxillofacial using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2023-12-15
X-ray/Radiography workflow
FDA-cleared K231587

MAGNETOM Cima.X

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-12-18
MRI workflow
FDA-cleared K231929

iQ-solutions

Sydney Neuroimaging Analysis Centre Pty Ltd

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-12-18
CT/CTA workflow
FDA-cleared K233176

uOmnispace.MI

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-12-20
CT/CTA workflow
FDA-cleared K231805

qXR-LN

Qure.ai Technologies

Image analysis/processing.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-12-22
X-ray/Radiography workflow
FDA-cleared K232479

ART-Plan

TheraPanacea

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2023-12-22
Radiotherapy planning
FDA-cleared K231130

TumorSight Viz

SimBioSys, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2023-12-26
Breast imaging
FDA-cleared K232412

LungQ v3.0.0

Thirona BV

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2024-01-08
Chest CT
FDA-cleared K233677

Biograph VK10

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-01-12
Nuclear medicine
FDA-cleared K233512

Rapid (6.0)

iSchemaView, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-01-16
CT/CTA workflow
FDA-cleared K232698

NemoScan

Software Nemotec S.L.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-01-18
CT/CTA workflow
FDA-cleared K232156

Rapid ASPECTS (v3)

iSchemaView, Inc.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-01-19
Nuclear medicine
FDA-cleared K233728

SIGNA Champion

GE Healthcare (Tianjin) Company Limited

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-01-19
MRI workflow
FDA-cleared K233080

HealthFLD

Nano-X AI Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-02-08
CT/CTA workflow
FDA-cleared K232765

MAGNETOM Cima.X Fit

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-02-29
MRI workflow
FDA-cleared K231690

iCAS-LV

HighRAD Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-03-01
CT/CTA workflow
FDA-cleared K233030

BoneMRI

MRIguidance B.V

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2024-03-01
MSK and bone
FDA-cleared K233968

CINA-iPE

Avicenna.AI

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-03-13
CT/CTA workflow
FDA-cleared K233342

CINA-ASPECTS

Avicenna.AI

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-03-15
Nuclear medicine
FDA-cleared K233753

AI-Rad Companion (Pulmonary)

Siemens Healthcare GmbH

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2024-03-21
Chest CT
FDA-cleared K240540

uMR Omega

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-03-22
MRI workflow
FDA-cleared K233657

NAEOTOM Alpha

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-03-28
CT/CTA workflow
FDA-cleared K233211

AVIEW CAC

Coreline Soft Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-03-29
CT/CTA workflow
FDA-cleared K233676

Us2.v2

Eko.ai Pte. Ltd d/b/a Us2.ai

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2024-04-01
Ultrasound workflow
FDA-cleared K240172

Preview Shoulder

Genesis Software Innovations

Image analysis/processing for Shoulder using CT/CTA.

Modality
CT/CTA
Anatomy
Shoulder
Decision
2024-04-04
CT/CTA workflow
FDA-authorized DEN230023

Rho

16 Bit Inc

Computer-aided detection/diagnosis

Modality
Modality not specified in FDA list
Anatomy
N/A
Decision
2024-04-09
Detection and CADe
FDA-cleared K240744

uMR 680

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-04-10
MRI workflow
FDA-cleared K233698

True Enhance DL

GE Healthcare Japan Corporation

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-04-11
CT/CTA workflow
FDA-cleared K233186

uOmnispace.MR

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-04-17
MRI workflow
FDA-cleared K233582

Rapid

iSchema View Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-04-22
CT/CTA workflow
FDA-cleared K233673

uMR Jupiter

Shanghai United Imaging Healthcare Co., Ltd

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-04-26
MRI workflow
FDA-cleared K232491

CT 5300

Philips Healthcare (Suzhou) Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-05-03
CT/CTA workflow
FDA-cleared K233687

ECHELON Synergy V10.0

Fujifilm Healthcare Americas Corporation

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-05-03
MRI workflow
FDA-cleared K233247

Heuron ICH

Heuron Co., Ltd.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2024-05-15
CT/CTA workflow
FDA-cleared K233209

uOmnispace.CT

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-05-17
CT/CTA workflow
FDA-cleared K233108

VinDr-Mammo

VinBigData Joint Stock Company

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2024-05-23
Breast imaging
FDA-cleared K234154

uPMR 790

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-05-24
Nuclear medicine
FDA-cleared K240769

LVivo IQS

DiA Imaging Analysis Ltd.

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2024-05-24
Ultrasound workflow
FDA-cleared K240612

CINA-VCF

Avicenna.AI

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-05-31
CT/CTA workflow
FDA-cleared K233925

Relu Creator

Relu BV

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-06-13
MRI workflow
FDA-cleared K233955

Clarius OB AI

Clarius Mobile Health Corp.

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2024-06-14
Ultrasound workflow
FDA-cleared K241083

SIS System

Surgical Information Sciences, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-06-14
CT/CTA workflow
FDA-cleared K233196

Medihub Prostate

JLK Inc.

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2024-06-21
Prostate imaging
FDA-cleared K240582

VEA Align; spineEOS

EOS imaging

Image analysis/processing for Spine using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2024-06-25
MSK and bone
FDA-cleared K241329

SubtleSYNTH (1.x)

Subtle Medical, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-07-11
MRI workflow
FDA-cleared K233457

RUS

Hutom Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2024-07-12
Breast imaging
FDA-cleared K240845

Rayvolve

AZmed SAS

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-07-17
Nuclear medicine
FDA-cleared K241121

MICSI-RMT

Microstructure Imaging, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-07-17
MRI workflow
FDA-cleared K233731

CardIQ Suite

GE Medical Systems SCS

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-01
CT/CTA workflow
FDA-cleared K233822

i2Contour

MRIMath LLC

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2024-08-08
Radiotherapy planning
FDA-cleared K241665

Omni Legend

GE Medical Systems Israel, Functional Imaging

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-08-08
Nuclear medicine
FDA-cleared K242054

OptimMRI (v2)

Rebrain, SAS

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-08-12
MRI workflow
FDA-cleared K241211

CoLumbo

Smart Soft Healthcare

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-08-15
MRI workflow
FDA-cleared K241596

uMI Panvivo

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-08-15
Nuclear medicine
FDA-cleared K240740

qCT LN Quant

Qure.ai Technologies

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-16
CT/CTA workflow
FDA-cleared K241440

HealthCCSng

Nano-X AI Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-19
CT/CTA workflow
FDA-cleared K240290

AiMIFY (1.x)

Subtle Medical, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-08-21
MRI workflow
FDA-cleared K241098

NeuroQuant

CorTechs Labs, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-08-22
MRI workflow
FDA-cleared K233826

Kosmos

EchoNous, Inc.

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2024-08-29
Ultrasound workflow
FDA-cleared K241585

uMI Panorama

Shanghai United Imaging Healthcare Co.,Ltd.

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-08-30
Nuclear medicine
FDA-cleared K242300

MI View&GO

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-08-30
CT/CTA workflow
FDA-cleared K233977

Velacur

Sonic Incytes

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2024-09-04
Ultrasound workflow
FDA-cleared K233998

TRAQinform IQ

AIQ Global, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-09-05
CT/CTA workflow
FDA-cleared K240411

uAI Portal

Shanghai United Imaging Intelligence Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-09-06
CT/CTA workflow
FDA-cleared K240791

ADAS 3D

Adas3D Medical S.L

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-09-09
CT/CTA workflow
FDA-cleared K240942

CINA-CSpine

Avicenna.AI

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-09-12
CT/CTA workflow
FDA-cleared K242292

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2024-09-24
CT/CTA workflow
FDA-cleared K241480

JBS-LVO

JLK, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2024-09-27
CT/CTA workflow
FDA-cleared K240943

LungVision

BodyVision Medical Ltd.

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2024-10-01
Chest CT
FDA-cleared K241331

MuscleView

Springbok, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-10-01
MRI workflow
FDA-cleared K241561

MammoScreen BD

Therapixel

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2024-10-02
Breast imaging
FDA-cleared K242652

Lunit INSIGHT DBT v1.1

Lunit Inc.

Image analysis/processing for Breast using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2024-10-04
Breast imaging
FDA-cleared K241242

SIGNA MAGNUS

GE Medical Systems, LLC

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-10-17
MRI workflow
FDA-cleared K243209

nordicMEDiVA

NordicNeurolab AS

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-10-22
MRI workflow
FDA-cleared K243189

TumorSight Viz

SimBioSys, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-10-25
MRI workflow
FDA-cleared K240712

icobrain aria

icometrix NV

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-11-07
Nuclear medicine
FDA-cleared K241719

NeuroICH

Neurocareai Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-11-07
CT/CTA workflow
FDA-cleared K242062

1CMR Pro

Mycardium AI Limited

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-11-15
MRI workflow
FDA-cleared K242130

Koios DS

Koios Medical, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2024-11-15
Breast imaging
FDA-cleared K241747

Saige-Dx

DeepHealth, Inc

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2024-11-18
Breast imaging
FDA-cleared K241831

Transpara (2.1.0)

ScreenPoint Medical B.V.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2024-11-25
Breast imaging
FDA-cleared K240645

Sonix Health

Ontact Health Co., Ltd

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-11-27
MRI workflow
FDA-cleared K242188

ClearRead CT CAC

Riverain Technologies, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-12-03
CT/CTA workflow
FDA-cleared K240680

CDM Insights

Oxford Brain Diagnostics Ltd

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-12-06
MRI workflow
FDA-cleared K240926

PeekMed web

Peek Health, S.A.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-12-06
CT/CTA workflow
FDA-cleared K242461

IRISeg

Intuitive Surgical Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-12-10
CT/CTA workflow
FDA-cleared K240793

MSKai

MSKai

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2024-12-16
CT/CTA workflow
FDA-cleared K242467

IQ-UIP

Imbio, Inc.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2024-12-19
Radiotherapy planning
FDA-cleared K243688

Saige-Dx (3.1.0)

DeepHealth, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2024-12-19
Breast imaging
FDA-cleared K242362

Lightning Viewer

Nexsys Electronics Inc. dba Medweb

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2024-12-20
Breast imaging
FDA-cleared K242334

Ezra Flash

Ezra AI, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-01-02
MRI workflow
FDA-cleared K241350

Clarify DL

GE Medical Systems Israel, Functional Imaging

Image analysis/processing.

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

JLK-ICH

JLK, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2025-01-03
CT/CTA workflow
FDA-cleared K241079

uCT 780

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-01-07
CT/CTA workflow
FDA-cleared K241891

ScreenDx

Imvaria, Inc

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2025-01-10
Radiotherapy planning
FDA-cleared K241166

uCT 550

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-01-14
CT/CTA workflow
FDA-cleared K242171

TechCare Trauma

Milvue

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2025-01-17
Nuclear medicine
FDA-cleared K243350

Rapid Neuro3D

iSchemaView, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-01-22
CT/CTA workflow
FDA-cleared K243229

Bunkerhill AVC

BunkerHill Health

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-01-27
CT/CTA workflow
FDA-cleared K243620

Vivid iq

GE Medical Systems Ultrasound and Primary Care Diagnostics

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-02-11
Ultrasound workflow
FDA-cleared K243628

Vivid T9/Vivid T8

GE Medical Systems Ultrasound and Primary Care Diagnostics

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-02-11
Ultrasound workflow
FDA-cleared K243250

SubtleHD (1.x)

Subtle Medical, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-02-12
MRI workflow
FDA-cleared K243696

AVIEW CAC

Coreline Soft Co., Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-02-14
CT/CTA workflow
FDA-cleared K242240

CaRi-Plaque

Caristo Diagnostics Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-02-20
CT/CTA workflow
FDA-cleared K242838

QuickRad

Aikenist Technologies Pvt Ltd

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2025-02-21
Breast imaging
FDA-cleared K243614

Sonio Suspect

Sonio

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2025-02-21
Nuclear medicine
FDA-cleared K241922

Myomics

Phantomics Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-02-28
CT/CTA workflow
FDA-cleared K243611

JLK-SDH

JLK, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-03-03
CT/CTA workflow
FDA-cleared K250379

SIGNA Prime Elite

GE Medical Systems, LLC

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-03-17
MRI workflow
FDA-cleared K243689

AVIEW

Coreline Soft Co., Ltd.

Image analysis/processing.

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

PeekMed web

Peek Health, S.A.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-03-19
CT/CTA workflow
FDA-cleared K243831

Rayvolve LN

AZmed

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-03-26
MRI workflow
FDA-cleared K242919

V5med Lung AI

V5med Inc.

Image analysis/processing for Chest/Lung using CT/CTA.

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

Salix Central

Artrya Limited

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-03-27
CT/CTA workflow
FDA-cleared K242166

TribusConnect

TribusMed Beheer BV

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-03-31
CT/CTA workflow
FDA-cleared K242295

BunkerHill BMD

BunkerHill Health

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-04-08
CT/CTA workflow
FDA-cleared K243145

syngo.CT LVO Detection

Siemens Medical Solutions USA, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2025-04-10
CT/CTA workflow
FDA-cleared K250754

cmAngio® (V1.6)

CureMetrix, Inc.

Image analysis/processing for Vascular using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Vascular
Decision
2025-04-10
Breast imaging
FDA-cleared K242748

Oncospace

Oncospace, Inc.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2025-04-11
Radiotherapy planning
FDA-cleared K250416

GBrain MRI

Galileo CDS, Inc

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-04-11
MRI workflow
FDA-cleared K242500

LARALAB

LARALAB GmbH

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-04-16
CT/CTA workflow
FDA-cleared K243853

Clarius Prostate AI

Clarius Mobile Health Corp.

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2025-04-16
Prostate imaging
FDA-cleared K243651

VersaViewer

GE Medical Systems SCS

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2025-04-21
Breast imaging
FDA-cleared K243239

Lung AI (LAI001)

Exo Inc

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-04-24
Chest CT
FDA-cleared K243376

uAngio AVIVA CX

Shanghai United Imaging Healthcare Co.,Ltd.

Image analysis/processing for Vascular using Fluoroscopy/Angiography.

Modality
Fluoroscopy/Angiography
Anatomy
Vascular
Decision
2025-04-28
Fluoroscopy/Angiography workflow
FDA-cleared K250087

Vscan Air

GE Medical Systems Ultrasound and Primary Care Diagnostics

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-05-01
Ultrasound workflow
FDA-cleared K240554

InferRead Lung CT.AI

Infervision Medical Technology Co., Ltd.

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-05-16
Chest CT
FDA-cleared K243122

uMR Omega

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-05-21
MRI workflow
FDA-cleared K242594

DEEPECHO

DeepEcho

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-05-23
Ultrasound workflow
FDA-cleared K243937

Accuro 3S

Rivanna Medical, Inc.

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-05-23
Ultrasound workflow
FDA-cleared K250005

Clever One

Ewoosoft Co., Ltd

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-05-23
CT/CTA workflow
FDA-cleared K243378

Rapid MLS

iSchemaview Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-05-28
CT/CTA workflow
FDA-cleared K250367

CoLumboX

Smart Soft Healthcare AD

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-05-28
MRI workflow
FDA-authorized DEN240047

Allix5

Clairity, Inc.

Computer-aided detection/diagnosis

Modality
Modality not specified in FDA list
Anatomy
N/A
Decision
2025-05-30
Detection and CADe
FDA-cleared K243667

Sonic DL

GE Medical Systems, LLC

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-06-05
MRI workflow
FDA-cleared K251153

Aurora

GE Medical Systems Israel

Image analysis/processing.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2025-06-12
Nuclear medicine
FDA-cleared K250685

Methinks NCCT Stroke

Methinks Software S.L.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2025-06-16
CT/CTA workflow
FDA-cleared K250440

RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT

Brainlab AG

Image analysis/processing for Neurovascular using Radiotherapy planning imaging.

Modality
Radiotherapy planning imaging
Anatomy
Neurovascular
Decision
2025-06-17
Radiotherapy planning
FDA-cleared K243672

CardIQ Suite

GE Medical Systems SCS

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-06-18
CT/CTA workflow
FDA-cleared K243647

Synapse PACS (7.5)

FUJIFILM Healthcare Americas Corporation

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2025-06-30
Breast imaging
FDA-cleared K251766

TumorSight Viz

SimBioSys, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-07-08
MRI workflow
FDA-cleared K251169

Vivid Pioneer

GE Medical Systems Ultrasound and Primary Care Diagnostics

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-07-10
Ultrasound workflow
FDA-cleared K251096

PeekMed web

Peek Health, S.A.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-07-14
CT/CTA workflow
FDA-cleared K243397

uMR 680

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-07-16
MRI workflow
FDA-cleared K243547

uMR Ultra

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-07-17
MRI workflow
FDA-cleared K250941

Revolution Vibe

GE Medical Systems, LLC

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-08-01
CT/CTA workflow
FDA-cleared K250246

uMR Jupiter

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-08-05
MRI workflow
FDA-cleared K251629

UNiD™ Spine Analyzer

Medicrea International S.A.S. (Medtronic)

Image analysis/processing for Spine using Radiological images; modality varies or is not specified in FDA list.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine
Decision
2025-08-07
MSK and bone
FDA-cleared K251873

Saige-Dx

DeepHealth, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2025-08-11
Breast imaging
FDA-cleared K251747

VEA Align; spineEOS

EOS imaging

Image analysis/processing for Spine using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2025-08-15
MSK and bone
FDA-cleared K251590

Methinks CTA Stroke

Methinks Software S.L.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2025-08-20
CT/CTA workflow
FDA-cleared K243685

MammoScreen BD

Therapixel

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2025-08-22
Breast imaging
FDA-cleared K252362

GBrain MRI

Galileo CDS, Inc

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-08-22
MRI workflow
FDA-cleared K250290

SurgiTwin

Twinsight

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-08-29
CT/CTA workflow
FDA-cleared K252539

Tempus Pixel

Arterys, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2025-09-03
Breast imaging
FDA-cleared K250064

Dose+ (1.0)

Mvision AI Oy

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2025-09-04
Radiotherapy planning
FDA-cleared K251610

qER-CTA (v1.0)

Qure.ai Technologies

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-09-08
CT/CTA workflow
FDA-cleared K251682

MuscleView 2.0

Springbok, Inc. (dba Springbok Analytics)

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-09-09
MRI workflow
FDA-cleared K244002

AngioWaveNet

Angiowave Imaging, Inc.

Image analysis/processing for Vascular using CT/CTA.

Modality
CT/CTA
Anatomy
Vascular
Decision
2025-09-10
CT/CTA workflow
FDA-cleared K251399

SIGNA™ Sprint

GE Medical Systems, LLC

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-09-11
MRI workflow
FDA-cleared K251368

FETOLY

Diagnoly

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-09-12
Ultrasound workflow
FDA-cleared K250237

InferOperate Suite

Beijing Infervision Healthcare Medical Technology Co., Ltd.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2025-09-15
Breast imaging
FDA-cleared K251386

ECHELON Synergy

Fujifilm Corporation

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-09-17
MRI workflow
FDA-cleared K250369

Axial3D Insight

Axial Medical Printing Limited

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-09-18
CT/CTA workflow
FDA-cleared K251002

Videa Dental AI

VideaHealth Inc.

Image analysis/processing for Dental/Maxillofacial using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-09-19
X-ray/Radiography workflow
FDA-cleared K251483

SwiftSight-Brain

AIRS Medical Inc.

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2025-09-23
Neuro MRI
FDA-cleared K251527

Brain WMH

Quantib BV

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2025-09-25
Neuro MRI
FDA-cleared K252371

uMR 680

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-09-25
MRI workflow
FDA-cleared K250023

SMART PCFD

Disior Ltd

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2025-09-29
Radiotherapy planning
FDA-cleared K250766

LungQ 4

Thirona BV

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-10-02
Chest CT
FDA-cleared K250662

Bunkerhill MAC

Bunkerhill Health

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-10-03
CT/CTA workflow
FDA-cleared K252007

BlineSlide

Deep Breathe, Inc.

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-10-06
Ultrasound workflow
FDA-cleared K252214

AIAS Cephalon

Metamorphosis GmbH

Image analysis/processing for Head/Neck using CT/CTA.

Modality
CT/CTA
Anatomy
Head/Neck
Decision
2025-10-07
CT/CTA workflow
FDA-cleared K252298

ANDI 2.0

Imeka Solutions, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-10-22
MRI workflow
FDA-cleared K251963

LOGIQ E10s

Ge Medical Systems Ultrasound and Primary Care Diagnostics

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-10-29
Ultrasound workflow
FDA-cleared K251985

LOGIQ E10

Ge Medical Systems Ultrasound and Primary Care Diagnostics

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-10-29
Ultrasound workflow
FDA-cleared K250337

AiORTA - Plan

ViTAA Medical Solutions, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-10-30
CT/CTA workflow
FDA-cleared K252452

PeekMed web

Peek Health, S.A.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-11-12
CT/CTA workflow
FDA-cleared K252217

CT VScore+

Canon Medical Informatics, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-11-28
CT/CTA workflow
FDA-cleared K251203

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd

Image analysis/processing for Chest/Lung using CT/CTA.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-12-03
Chest CT
FDA-cleared K250780

ARTAssistant

Manteia Technologies Co., Ltd.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2025-12-05
Radiotherapy planning
FDA-cleared K252482

CogNet AI-MT+

Medcognetics, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2025-12-11
Breast imaging
FDA-cleared K251763

IRISeg

Intuitive Surgical, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-12-16
CT/CTA workflow
FDA-cleared K252922

Neosoma Brain Mets

Neosoma, Inc.

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2025-12-17
Neuro MRI
FDA-cleared K252029

AI-CVD

HeartLung Corporation

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-12-19
CT/CTA workflow
FDA-cleared K252670

Alzevita

TOPIA MEDTECH LIMITED

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-12-19
MRI workflow
FDA-cleared K250959

BioticsAI

Bioticsai, Inc.

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-12-22
Ultrasound workflow
FDA-cleared K252856

PeekMed web

Peek Health, S.A.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-12-22
CT/CTA workflow
FDA-cleared K252379

AIR Recon DL

Ge Medical Systems, LLC

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-12-23
MRI workflow