# IZO: Generator, High-Voltage, X-Ray, Diagnostic

- Device class: 1; regulation: 21 CFR 892.1700; FDA's rule: 510(k) exempt
- FDA decisions: 163
- Recalls: 5 (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)
- 1986: 6
- 1987: 6
- 1988: 21
- 1989: 9
- 1990: 10
- 1991: 25
- 1992: 11
- 1993: 15
- 1994: 12
- 1995: 14

## Most-cited predicates
- K950883: Polydoros SX 65 and 80 (1995), cited by 1
- K944149: Micro X-80 HF (1994), cited by 1
- K945668: KXO-80G (1994), cited by 1

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