# Stephanix

- Location (FDA's records): La Ricamarie, FR
- FDA decisions: 3 (2021–2022): 3 510(k) clearances
- Product codes: OWB (2), IZL (1)
- 510(k) review time since 2016: median 55 days, against 60 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 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
- Sedecal., Sa.: 1 (https://510kreport.com/company/sedecal)
- Stephanix Radiological Systems: 1 (https://510kreport.com/company/stephanix-radiological-systems)

## Its most-cited devices
- K213479: D²RS and D²RS 9090 (2021), cited by 1

## Recent decisions
- K221335: D²RS and D²RS 9090 (Jun 7, 2022)
- K213479: D²RS and D²RS 9090 (Dec 23, 2021)
- K212515: MOVIX DReamy (Nov 3, 2021)

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