Medical Device Manufacturer · FR , Valbonne

Therapixel - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2020

Total

Cleared

Denied

Therapixel has 6 FDA 510(k) cleared medical devices. Based in Valbonne, FR.

Latest FDA clearance: Aug 2025. Active since 2020. Primary specialty: Radiology.

Browse the FDA 510(k) cleared devices submitted by Therapixel Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Domecus Consulting Services, LLC and MCRA an IQVIA Business. 2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - Therapixel

6 devices

1-6 of 6

Regulatory Intelligence

PCCP authorized FDA software change control pathway

Regulatory consultants 510(k) submission support ecosystem

Domecus Consulting Services, LLC

MCRA an IQVIA Business

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026

Therapixel - FDA 510(k) Cleared Devices

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