Breast — AI devices

FDA-cleared and EU CE-marked radiology AI devices tagged Breast, 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

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

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

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

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

BreastUS

Lunit INSIGHT DBT

🇰🇷Lunit, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (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

BreastUS

Genius AI Detection 2.0

🇺🇸Hologic, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (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

BreastUS

BU-CAD

TaiHao Medical Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (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

BreastUS

Transpara 1.7.0

ScreenPoint Medical B.V.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2021

BreastUS

ProFound AI Software V3.0

🇺🇸iCAD, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2021

BreastUS

Genius AI Detection

🇺🇸Hologic, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2020

BreastUS

MammoScreen

🇺🇸Therapixel

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2020

BreastUS

Transpara

ScreenPoint Medical B.V.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2020

BreastUS

Transpara

ScreenPoint Medical B.V.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2019

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