# JJJ: Counter (Beta, Gamma) For Clinical Use

- Device class: 1; regulation: 21 CFR 862.2320; FDA's rule: 510(k) exempt
- FDA decisions: 63
- Recalls: 7 (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)
- 1983: 8
- 1984: 3
- 1985: 3
- 1986: 1
- 1987: 4
- 1989: 3
- 1990: 2
- 1992: 1
- 1995: 1
- 1996: 1

## Most-cited predicates
- K770088: Gamma 4000 Scintillation Counter (1977), cited by 1

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