# Reflexion Medical, Inc.

- Location (FDA's records): Hayward, CA
- FDA decisions: 3 (2020–2025): 2 510(k) clearances and 1 De Novo grant
- Product codes: QVA (2), IYE (1)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Accuray Incorporated: 1 (https://510kreport.com/company/accuray)

## Its most-cited devices
- DEN220014: RefleXion Medical Radiotherapy System (RMRS) (2023), cited by 1

## Recent decisions
- K252071: RefleXion Medical Radiotherapy System, Reflexion X2 (Dec 18, 2025)
- DEN220014: RefleXion Medical Radiotherapy System (RMRS) (Feb 1, 2023)
- K190978: RefleXion Medical Radiotherapy System (Mar 12, 2020)

Source page: https://510kreport.com/company/reflexion-medical