Detection and CADe radiology AI tools

FDA-cleared K253796

Lunit INSIGHT DBT (V1.2)

Lunit, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2026-03-26

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K253578

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

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: Chest/Lung
Decision: 2026-02-26

Detection and CADe Acute triage and notification Chest CT

FDA-cleared K251474

Median LCS (internal name) / eyonis LCS (trade name) (1.0)

Median Technologies

eyonis LCS is a concurrent-reading aid for radiologists that detects, localizes, and characterizes 4-30 mm solid and part-solid pulmonary nodules on low-dose chest CT images for...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2026-02-06

Lung nodule detection Detection and CADe Quantification and segmentation

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

Detection and CADe Acute triage and notification

FDA-cleared K252970

BriefCase-Triage: CARE Multi-triage CT Body

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: 2026-01-07

Detection and CADe Acute triage and notification

FDA-cleared K252482

CogNet AI-MT+

Medcognetics, Inc.

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

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-12-11

Breast imaging Detection and CADe Acute triage and notification

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

Detection and CADe Chest CT

FDA-cleared K250694

Scaida BrainCT-ICH (v1.0)

Mlhealth 360

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: 2025-11-25

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K251533

Rapid Obstructive Hydrocephalus, Rapid OH

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: Head/Neck
Decision: 2025-09-04

Detection and CADe Acute triage and notification

FDA-cleared K251983

Brainomix 360 Triage Stroke

Brainomix 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: Brain
Decision: 2025-08-26

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K251873

Saige-Dx

DeepHealth, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-08-11

Breast imaging Detection and CADe

FDA-cleared K243341

Genius AI Detection 2.0

Hologic, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-07-31

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

FDA-cleared K243884

TAVIPILOT

Caranx Medical

TAVIPILOT detects, tracks, and marks the non-coronary cusp and prosthetic valve on live fluoroscopy during specified adult femoral TAVR or TAVI procedures under physician control.

Modality: Fluoroscopy/Angiography
Anatomy: Heart/Cardiovascular
Decision: 2025-07-07

Cardiac imaging Detection and CADe

FDA-cleared K243679

MammoScreen® (4)

Therapixel

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2025-07-03

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

FDA-cleared K243667

Sonic DL

GE Medical Systems, LLC

Sonic DL is optional integrated GE MRI reconstruction for supported 2D cardiac cine and 3D fast-spin-echo or gradient-echo acquisitions at 1.5T, 3T, and 7T for all ages and...

Modality: MRI
Anatomy: Multi-region
Decision: 2025-06-05

Cardiac imaging Detection and CADe

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

Detection and CADe Acute triage and notification

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

Detection and CADe Chest CT

FDA-cleared K250831

Annalise Enterprise

Annalise-AI

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

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2025-04-23

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Chest CT

FDA-cleared K243808

Rayvolve PTX-PE

AZmed

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

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2025-03-21

Detection and CADe Acute triage and notification

FDA-cleared K242683

QP-Prostate® CAD

Quibim S.L.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: MRI
Anatomy: Prostate
Decision: 2025-03-18

Breast imaging Prostate imaging Detection and CADe

FDA-cleared K241770

Prostate MR AI (VA10A)

Siemens Healthcare GmbH

Prostate MR AI is a concurrent reading aid for radiologists interpreting prostate MRI examinations acquired according to the PI-RADS standard, assisting with detection and...

Modality: MRI
Anatomy: Prostate
Decision: 2025-03-05

Prostate imaging Detection and CADe

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

Detection and CADe Acute triage and notification

FDA-cleared K242821

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)

Ever Fortune.AI, 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: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2025-02-20

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K242171

TechCare Trauma

Milvue

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2025-01-17

MSK and bone Detection and CADe

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

Detection and CADe Acute triage and notification

FDA-cleared K243688

Saige-Dx (3.1.0)

DeepHealth, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-12-19

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

FDA-cleared K241923

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

Ever Fortune.AI, 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: 2024-12-06

Detection and CADe Acute triage and notification

FDA-cleared K241831

Transpara (2.1.0)

ScreenPoint Medical B.V.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-11-25

Breast imaging Detection and CADe

FDA-cleared K241747

Saige-Dx

DeepHealth, Inc

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-11-18

Breast imaging Detection and CADe

FDA-cleared K241439

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

Vuno Inc.

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

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2024-11-15

Detection and CADe Acute triage and notification

FDA-cleared K240417

ProFound Detection (V4.0)

iCAD, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-11-08

Breast imaging Detection and CADe

FDA-cleared K240712

icobrain aria

icometrix NV

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: MRI
Anatomy: Brain
Decision: 2024-11-07

MSK and bone Detection and CADe Neuro MRI

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K242652

Lunit INSIGHT DBT v1.1

Lunit Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2024-10-04

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K240942

CINA-CSpine

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: Spine
Decision: 2024-09-12

MSK and bone Detection and CADe Acute triage and notification

FDA-cleared K240697

See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

See-Mode Technologies Pte. Ltd.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Ultrasound
Anatomy: N/A
Decision: 2024-09-09

Breast imaging Detection and CADe Ultrasound workflow

FDA-cleared K240301

MammoScreen® (3)

Therapixel

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2024-08-01

Breast imaging Detection and CADe

FDA-cleared K240845

Rayvolve

AZmed SAS

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2024-07-17

MSK and bone Detection and CADe

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K233108

VinDr-Mammo

VinBigData Joint Stock Company

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

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2024-05-23

Breast imaging Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K232410

SmartChest

Milvue

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

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2024-05-10

Detection and CADe Acute triage and notification

FDA-cleared K240291

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

Ever Fortune.AI, 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: Cardiovascular
Decision: 2024-04-08

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K231871

Radify Triage

Envisionit DeepAI Ltd

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

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2024-01-17

Detection and CADe Acute triage and notification

FDA-cleared K232496

Brainomix 360 Triage Stroke

Brainomix 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: Brain
Decision: 2023-11-21

Detection and CADe Acute triage and notification

FDA-cleared K223754

BraveCX

Bering Ltd

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

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2023-11-09

Detection and CADe Acute triage and notification

FDA-cleared K231470

Lunit INSIGHT DBT

Lunit Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2023-11-06

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K231025

EFAI NeuroSuite CT ICH Assessment System

Ever Fortune.AI 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: 2023-10-04

Detection and CADe Acute triage and notification

FDA-cleared K232712

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Multi-region
Decision: 2023-10-03

Oncology quantification Detection and CADe Quantification and segmentation

FDA-cleared K231837

Brainomix 360 Triage LVO

Brainomix 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: Brain
Decision: 2023-09-28

Detection and CADe Acute triage and notification

FDA-cleared K231384

Annalise Enterprise CTB Triage Trauma

Annalise-AI 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: 2023-09-22

Detection and CADe Acute triage and notification

FDA-cleared K231767

Annalise Enterprise CTB Triage Trauma

Annalise-AI 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: 2023-09-22

Detection and CADe Acute triage and notification

FDA-cleared K230899

qXR-PTX-PE

Qure.ai Technologies

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

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2023-08-22

Detection and CADe Acute triage and notification

FDA-cleared K231094

Annalise Enterprise CTB Triage-OH

Annalise-AI 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: 2023-08-15

Detection and CADe Acute triage and notification

FDA-cleared K230074

Rapid Aneurysm Triage and Notification

iSchemaView 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: 2023-07-27

Detection and CADe Acute triage and notification

FDA-cleared K231195

Brainomix 360 Triage ICH

Brainomix 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: Brain
Decision: 2023-07-27

Detection and CADe Acute triage and notification

FDA-cleared K231572

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama GS combines 148 cm axial-field-of-view PET with CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Multi-region
Decision: 2023-07-26

Detection and CADe Quantification and segmentation Nuclear medicine

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

Detection and CADe Chest CT

FDA-cleared K223491

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

GE Medical Systems, LLC

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-05-25

MSK and bone Detection and CADe

FDA-cleared K230096

Genius AI Detection 2.0 with CC-MLO Correlation

Hologic, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2023-05-23

Breast imaging Detection and CADe

FDA-cleared K223240

Annalise Enterprise CTB Triage Trauma

Annalise-AI 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: 2023-04-03

Detection and CADe Acute triage and notification

FDA-cleared K222179

Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd

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

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-03-28

Detection and CADe Acute triage and notification

FDA-cleared K222268

Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd

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

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-03-28

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K223325

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Multi-region
Decision: 2023-03-10

Oncology quantification Detection and CADe Quantification and segmentation

FDA-cleared K222176

BoneView

Gleamer

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: Bone
Decision: 2023-03-02

MSK and bone Detection and CADe

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

Detection and CADe Acute triage and notification

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

Detection and CADe Chest CT

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K221330

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: X-ray/Radiography
Anatomy: N/A
Decision: 2022-11-18

Detection and CADe Acute triage and notification

FDA-cleared K221552

EFAI ChestSuite XR Pneumothorax Assessment System

Ever Fortune AI 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: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-11-08

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K221305

AI-Rad Companion Organs RT

Siemens Medical Solutions USA, Inc

AI-Rad Companion Organs RT VA40 automatically contours predefined structures from adult DICOM CT for qualified review and DICOM RTSTRUCT transfer; this release added 29...

Modality: Radiotherapy Planning Imaging
Anatomy: Multi-region
Decision: 2022-10-14

Radiotherapy planning Detection and CADe

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

Detection and CADe Acute triage and notification

FDA-cleared K221449

Genius AI Detection 2.0

Hologic, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-10-06

Breast imaging Detection and CADe

FDA-cleared K220080

CogNet QmTRIAGE

MedCognetics, Inc.

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

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-09-29

Breast imaging Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K222076

EFAI ChestSuite XR Pleural Effusion Assessment System

Ever Fortune.AI 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: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-09-08

Detection and CADe Acute triage and notification

FDA-cleared K221241

DrAid for Radiology v1

VinBrain Joint Stock Company

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

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2022-09-01

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K221347

Transpara 1.7.2

ScreenPoint Medical B.V.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-08-03

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

FDA-cleared K212783

ProstatID

ScanMed, LLC

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: MRI
Anatomy: N/A
Decision: 2022-07-08

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

FDA-cleared K220164

Rayvolve

AZmed SAS

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2022-06-02

MSK and bone Detection and CADe

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

Detection and CADe Acute triage and notification

FDA-cleared K220499

Rapid PE Triage and Notification (PETN)

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: 2022-05-17

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K220589

MAGNETOM Skyra Fit

Siemens Medical Solutions USA, Inc.

MAGNETOM Skyra Fit with syngo MR XA50A is a 3T system for broad head, body, and extremity MRI; this release includes TSE motion correction and automatic breast-biopsy fiducial...

Modality: MRI
Anatomy: Multi-region
Decision: 2022-05-13

Breast imaging Detection and CADe

FDA-cleared K220105

Saige-Dx

DeepHealth, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-05-12

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K214043

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: X-ray/Radiography
Anatomy: N/A
Decision: 2022-03-14

Detection and CADe Acute triage and notification

FDA-cleared K213566

ClearRead Xray Pneumothorax

Riverain Technologies, Inc.

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

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-03-10

Detection and CADe Acute triage and notification

FDA-cleared K212365

BoneView

Gleamer

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Bone
Decision: 2022-03-01

MSK and bone Detection and CADe Nuclear medicine

FDA-cleared K213941

Annalise Enterprise CXR Triage Pneumothorax

Annalise-AI

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

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-02-24

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe

FDA-cleared K210670

BU-CAD

TaiHao Medical Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Ultrasound
Anatomy: N/A
Decision: 2021-12-21

Breast imaging Detection and CADe Ultrasound workflow

FDA-cleared K211803

HealthPPT

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: X-ray/Radiography
Anatomy: N/A
Decision: 2021-12-15

Detection and CADe Acute triage and notification

FDA-cleared K211541

MammoScreen 2.0

Therapixel

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2021-11-26

Breast imaging Detection and CADe

FDA-cleared K211678

Lunit INSIGHT MMG

Lunit Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-11-17

Breast imaging Detection and CADe

FDA-cleared K211733

Lunit INSIGHT CXR Triage

Lunit Inc.

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

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2021-11-10

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K211945

V8 Diagnostic Ultrasound System

Samsung Medison CO., LTD.

Samsung V8 is a general diagnostic ultrasound system for broad hospital, clinic, and practice applications; K211945 adds thoracic scanning, AI-based NerveTrack, and AI-based...

Modality: Ultrasound
Anatomy: Multi-region
Decision: 2021-09-08

Detection and CADe Quantification and segmentation Ultrasound workflow

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K210404

Transpara 1.7.0

ScreenPoint Medical B.V.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-06-02

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification Chest CT

FDA-cleared K203517

Saige-Q

DeepHealth, Inc.

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

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-04-16

Breast imaging Detection and CADe Acute triage and notification

FDA-cleared K202992

BriefCase, RIB Fractures Triage (RibFx)

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: Bone
Decision: 2021-04-14

MSK and bone Detection and CADe Acute triage and notification

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

Detection and CADe Chest CT

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

Detection and CADe Acute triage and notification

FDA-cleared K203822

ProFound AI Software V3.0

iCAD Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-03-12

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K201019

Genius AI Detection

Hologic, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2020-11-18

Breast imaging Detection and CADe

FDA-cleared K193562

AI-Rad Companion Organs RT

Siemens Medical Solutions USA, Inc.

AI-Rad Companion Organs RT VA20 automatically contours predefined organs at risk from adult DICOM CT for qualified review, editing, and DICOM RTSTRUCT transfer into...

Modality: Radiotherapy Planning Imaging
Anatomy: Multi-region
Decision: 2020-11-06

Radiotherapy planning Detection and CADe

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K193417

FractureDetect (FX)

Imagen Technologies, Inc.

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: Bone
Decision: 2020-07-30

MSK and bone Detection and CADe

FDA-cleared K200905

HealthMammo

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: Mammography/DBT
Anatomy: Breast
Decision: 2020-07-16

Breast imaging Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Chest CT

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K193300

AIMI-Triage CXR PTX

RADLogics, Inc.

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

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2020-04-08

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K192854

MammoScreen

Therapixel

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2020-03-25

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

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

Detection and CADe Chest CT

FDA-cleared K191556

Red Dot

Behold.AI Technologies Limited

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

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2020-02-28

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K192320

HealthCXR

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: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2019-11-26

Detection and CADe Acute triage and notification

FDA-cleared K191994

ProFound AI Software V2.1

iCAD Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2019-10-04

Breast imaging Detection and CADe

FDA-cleared K183182

Critical Care Suite

GE Medical Systems, LLC.

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

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2019-08-12

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K190362

HealthPNX

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: X-ray/Radiography
Anatomy: N/A
Decision: 2019-05-06

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-cleared K183285

cmTriage

CureMetrix, Inc

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

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2019-03-08

Breast imaging Detection and CADe Acute triage and notification

FDA-cleared K182373

PowerLook Tomo Detection V2 Software

iCAD Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2018-12-06

Breast imaging Detection and CADe

FDA-cleared K181704

Transpara

ScreenPoint Medical BV

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2018-11-21

Breast imaging Detection and CADe

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

Detection and CADe Acute triage and notification

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

Detection and CADe Acute triage and notification

FDA-authorized DEN180005

OsteoDetect

Imagen Technologies, Inc.

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2018-05-24

MSK and bone Detection and CADe

FDA-approved P160009

PowerLook® Tomo Detection Software

iCAD Inc

PowerLook Tomo Detection Software is a concurrent computer-aided detection tool for radiologists reading GE Senoclaire breast tomosynthesis examinations; it detects soft-tissue...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2017-03-24

Breast imaging Detection and CADe

FDA-cleared K161959

ClearView cCAD

ClearView Diagnostics Inc.

ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images.

Modality: Ultrasound
Anatomy: Breast
Decision: 2016-12-28

Breast imaging Detection and CADe Ultrasound workflow

FDA-approved P150043

QVCAD System

QView Medical, Inc.

QVCAD assists readers during breast screening by searching three-dimensional images from an Automated Breast Ultrasound System for mammography-occult lesions in regions without...

Modality: Ultrasound
Anatomy: N/A
Decision: 2016-11-09

Breast imaging Detection and CADe Ultrasound workflow

FDA-cleared K161382

LVivo Software Application

DIACARDIO, LTD.

LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular...

Modality: Ultrasound
Anatomy: Heart
Decision: 2016-07-28

Cardiac imaging Detection and CADe Quantification and segmentation

FDA-approved P010034

SECOND LOOK ™

ICAD, INC.

Second Look is a computer-aided detection system for mammography that marks regions of interest on standard mammographic views after the initial reading to help radiologists...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2002-01-31

Breast imaging Detection and CADe

FDA-approved P980025

LOGICON CARIES DETECTOR

CARESTREAM DENTAL LLC

LOGICON Caries Detector is adjunct software for detecting caries extending into dentin on unrestored proximal surfaces of secondary dentition in supported digital intraoral...

Modality: X-ray/Radiography
Anatomy: Dental/Maxillofacial
Decision: 1998-09-02

Detection and CADe