# IYI: Collimator, Orthovoltage, Therapeutic X-Ray

- Device class: 2; regulation: 21 CFR 892.5900; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 1990: 1
- 1992: 1

## Most-cited predicates
- K900932: 37-702 and 37-703 PC Rainbow (1990), cited by 1

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