# ITY: Assembly, Tube Housing, X-Ray, Diagnostic

- Device class: 1; regulation: 21 CFR 892.1760; FDA's rule: 510(k) exempt
- FDA decisions: 40
- Recalls: 4 (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)
- 1984: 1
- 1986: 3
- 1987: 3
- 1988: 2
- 1989: 2
- 1990: 2
- 1991: 6
- 1992: 8
- 1993: 3
- 2000: 1

## Most-cited predicates
- K904182: R-800-SF (1990), cited by 1

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