# JAC: System, X-Ray, Film Marking, Radiographic

- Device class: 1; regulation: 21 CFR 892.1640; FDA's rule: 510(k) exempt
- FDA decisions: 18
- Recalls: 8 (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)
- 1985: 1
- 1987: 2
- 1988: 1
- 1989: 1
- 1991: 4
- 1992: 3
- 1993: 5
- 1994: 1

## Most-cited predicates
- K930752: CT/Mri Topographic Marker (1993), cited by 1

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