# IWM: Synchrotron, Medical

- Device class: 2; regulation: 21 CFR 892.5050; FDA's rule: 510(k) required
- FDA decisions: 1
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1988: 1

## Most-cited predicates
- K872369: Loma Linda Univ. Proton Beam Therapy System (1988), cited by 9

Source page: https://510kreport.com/product-code/IWM
Data by year (CSV): https://510kreport.com/product-code/IWM.csv