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.

BreastUS

Lunit INSIGHT DBT (V1.2)

🇰🇷Lunit, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2026
BreastUS

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

Median Technologies

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2026
US

CogNet AI-MT+

🇺🇸Medcognetics, Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2025
BreastUS

Saige-Dx

DeepHealth, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2025
BreastUS

Genius AI Detection 2.0

🇺🇸Hologic, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2025
BreastUS

MammoScreen® (4)

🇺🇸Therapixel

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2025
US

Annalise Enterprise

🇦🇺Annalise.ai

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2025
US

Rayvolve PTX-PE

🇺🇸AZmed

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2025
BreastUS

QP-Prostate® CAD

🇪🇸Quibim S.L.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2025
BreastUS

Prostate MR AI (VA10A)

🇩🇪Siemens Healthcare GmbH

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2025
BreastUS

Saige-Dx (3.1.0)

DeepHealth, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2024
US

BriefCase-Triage

🇮🇱Aidoc Medical , Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2024
BreastUS

Transpara (2.1.0)

ScreenPoint Medical B.V.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2024
BreastUS

Saige-Dx

DeepHealth, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2024
US

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

🇰🇷Vuno Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2024
BreastUS

ProFound Detection (V4.0)

🇺🇸iCAD, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2024
BreastUS

Lunit INSIGHT DBT v1.1

🇰🇷Lunit, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2024
BreastUS

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

See-Mode Technologies Pte. Ltd.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2024
BreastUS

MammoScreen® (3)

🇺🇸Therapixel

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2024
US

CINA-VCF

🇫🇷Avicenna.AI

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2024
US

VinDr-Mammo

VinBigData Joint Stock Company

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2024
US

SmartChest

🇫🇷Milvue

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2024
US

Radify Triage

Envisionit DeepAI Ltd

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2024
US

BraveCX

Bering Ltd

Lesion detection/diagnosis software

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

Lunit INSIGHT DBT

🇰🇷Lunit, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2023
US

qXR-PTX-PE

🇮🇳Qure.Ai Technologies

Lesion detection/diagnosis software

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

Rapid Aneurysm Triage and Notification

🇺🇸iSchemaView, Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2023
BreastUS + EU

Lunit INSIGHT DBT

🇰🇷Lunit

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2023
BreastUS

Genius AI Detection 2.0 with CC-MLO Correlation

🇺🇸Hologic, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2023
US

Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2023
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