# KPZ: Generator, High Voltage, X-Ray, Therapeutic

- Device class: 2; regulation: 21 CFR 892.5900; FDA's rule: 510(k) required
- FDA decisions: 3
- Recalls: 0 (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: 2
- 1991: 1

## Most-cited predicates
- K912249: Patient Dose Monitor (1991), cited by 2

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