# IXL: Device, Spot-Film

- Device class: 2; regulation: 21 CFR 892.1670; FDA's rule: 510(k) exempt
- FDA decisions: 13
- Recalls: 3 (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)
- 1980: 1
- 1981: 1
- 1984: 1
- 1988: 2
- 1990: 2
- 1992: 1
- 1994: 2
- 1995: 1
- 1997: 1
- 2011: 1

## Most-cited predicates
- K924593: Diagnost 76 Family*R/F Systems - Release 4.4 (1992), cited by 1

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