# QBS: Radiological Computer Assisted Detection/Diagnosis Software For Fracture

- Device class: 2; regulation: 21 CFR 892.2090; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 185 days (middle half 155–219)
- 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)
- 2018: 1
- 2020: 1
- 2022: 2
- 2023: 2
- 2024: 2
- 2025: 1
- 2026: 3

## Most-cited predicates
- DEN180005: OsteoDetect (2018), cited by 4
- K212365: BoneView (2022), cited by 2
- K193417: FractureDetect (FX) (2020), cited by 2
- K240845: Rayvolve (2024), cited by 1
- K220164: Rayvolve (2022), cited by 1
- K222176: BoneView (2023), cited by 1
- K260378: Rayvolve (2026), cited by 1

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