# JWM: System, Tomographic, Nuclear

- Device class: 2; regulation: 21 CFR 892.1310; FDA's rule: 510(k) required
- FDA decisions: 17
- 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)
- 1978: 2
- 1980: 1
- 1981: 2
- 1983: 1
- 1984: 1
- 1985: 4
- 1987: 1
- 1988: 1
- 1990: 1
- 1991: 3

## Most-cited predicates
- K903315: ICON (1991), cited by 3
- K914350: Icon Computer System (1991), cited by 3

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