# QVA: Fludeoxyglucose F18-Guided Radiation Therapy System

- Device class: 2; regulation: 21 CFR 892.5060; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 170 days (middle half 170–170)
- 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)
- 2023: 1
- 2025: 1

## Most-cited predicates
- DEN220014: RefleXion Medical Radiotherapy System (RMRS) (2023), cited by 1

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