# IXA: Cassette, Radiographic Film

- Device class: 2; regulation: 21 CFR 892.1850; FDA's rule: 510(k) exempt
- FDA decisions: 51
- Recalls: 1 (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)
- 1995: 7
- 1996: 2
- 1997: 3
- 1998: 1
- 1999: 1
- 2001: 3
- 2002: 2
- 2004: 1
- 2005: 1
- 2008: 1

## Most-cited predicates
- K980722: Trimax Radiographic Cassette (1998), cited by 2
- K890750: Kodak X-Omatic RA Cassette (1989), cited by 1
- K890361: Kodak Min-R 2 Cassette (1989), cited by 1
- K963914: CM & CM DS-7 (1997), cited by 1

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