# Therapixel

- Location (FDA's records): Nice, FR
- FDA decisions: 7 (2020–2026): 7 510(k) clearances
- Product codes: QDQ (5), QIH (2)
- 510(k) review time since 2016: median 182 days, against 154 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Screenpoint Medical B.V.: 1 (https://510kreport.com/company/screenpoint-medical)
- Whiterabbit.Ai, Inc.: 1 (https://510kreport.com/company/whiterabbit-ai)

## Its most-cited devices
- K192854: MammoScreen (2020), cited by 1
- K240301: MammoScreen® (3) (2024), cited by 1
- K211541: MammoScreen 2.0 (2021), cited by 1
- K241561: MammoScreen BD (2024), cited by 1
- K243679: MammoScreen® (4) (2025), cited by 1

## Recent decisions
- K260714: MammoScreen® (5) (Jun 26, 2026)
- K243685: MammoScreen BD (Aug 22, 2025)
- K243679: MammoScreen® (4) (Jul 3, 2025)
- K241561: MammoScreen BD (Oct 2, 2024)
- K240301: MammoScreen® (3) (Aug 1, 2024)
- K211541: MammoScreen 2.0 (Nov 26, 2021)
- K192854: MammoScreen (Mar 25, 2020)

Source page: https://510kreport.com/company/therapixel