Medical Device Manufacturer · FR , Valbonne

Therapixel - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2020

Recent clearances: MammoScreen® (5), MammoScreen BD, MammoScreen® (4)

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Therapixel Radiology ✕

7 devices

1-7 of 7

Cleared Jun 26, 2026

MammoScreen® (5)

Radiology · 113d

Cleared Aug 22, 2025

Radiology · 266d

Cleared Jul 03, 2025

MammoScreen® (4)

Radiology · 216d

Cleared Oct 02, 2024

Radiology · 124d

Cleared Aug 01, 2024

MammoScreen® (3)

Radiology · 182d

Cleared Nov 26, 2021

MammoScreen 2.0

Radiology · 191d

Cleared Mar 25, 2020

Radiology · 173d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Jul 06, 2026