# Accuthera, Inc.

- Location (FDA's records): Kawasaki, JP
- FDA decisions: 1 (2015–2015): 1 510(k) clearance
- Product codes: IYE (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 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
- Accuray Incorporated: 1 (https://510kreport.com/company/accuray)

## Recent decisions
- K143560: CygneX I System (Oct 5, 2015)

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