AI Devices

Detection (CADe)

Radiology AI devices in the Detection (CADe) category, FDA-cleared or EU CE-marked, newest clearance first. Information only, never clinical advice.

US

Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2023
US

Viz AAA

🇺🇸Viz.ai, Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2023
Chest / ThoracicUS + EU

Annalise Enterprise CXR

🇦🇺Annalise.ai

Lesion detection/diagnosis software

X-ray / DRDetection (CADe)510(k) 2023
US

BriefCase

🇮🇱Aidoc Medical , Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2023
US

QOCA image Smart CXR Image Processing System

🇹🇼Quanta Computer Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2023
US

BriefCase

🇮🇱Aidoc Medical , Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2022
US

EFAI ChestSuite XR Pneumothorax Assessment System

Ever Fortune.Ai, Co., Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2022
BreastUS

Genius AI Detection 2.0

🇺🇸Hologic, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2022
US

CogNet QmTRIAGE

🇺🇸Medcognetics, Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2022
US

EFAI ChestSuite XR Pleural Effusion Assessment System

Ever Fortune.Ai, Co., Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2022
US

DrAid for Radiology v1

VinBrain Joint Stock Company

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2022
BreastUS

Transpara 1.7.2

ScreenPoint Medical B.V.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2022
BreastUS

ProstatID

🇺🇸ScanMed, LLC

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2022
BreastUS

Saige-Dx

DeepHealth, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2022
US

BriefCase

🇮🇱Aidoc Medical , Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2022
US

ClearRead Xray Pneumothorax

Riverain Technologies, Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2022
US

Annalise Enterprise CXR Triage Pneumothorax

🇦🇺Annalise.ai

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2022
US

Viz ANEURYSM, Viz ANX

🇺🇸Viz.ai, Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2022
BreastUS

BU-CAD

TaiHao Medical Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2021
US

HealthPPT

Zebra Medical Vision Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2021
BreastUS

MammoScreen 2.0

🇺🇸Therapixel

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2021
BreastUS

Lunit INSIGHT MMG

🇰🇷Lunit, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2021
US

Lunit INSIGHT CXR Triage

🇰🇷Lunit, Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2021
BreastUS

Transpara 1.7.0

ScreenPoint Medical B.V.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2021
US

Saige-Q

DeepHealth, Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2021
US

BriefCase, RIB Fractures Triage (RibFx)

🇮🇱Aidoc Medical , Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2021
BreastUS

ProFound AI Software V3.0

🇺🇸iCAD, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2021
US

uAI EasyTriage-Rib

Shanghai United Imaging Intelligence Co., Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2021
BreastUS

Genius AI Detection

🇺🇸Hologic, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2020
US

HealthMammo

Zebra Medical Vision Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2020
NewerPage 2 of 3Older