# QFM: Radiological Computer-Assisted Prioritization Software For Lesions

- Device class: 2; regulation: 21 CFR 892.2080; FDA's rule: 510(k) required
- FDA decisions: 41
- 510(k) review time 2021–2025: median 144 days (middle half 95–210)
- 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)
- 2019: 4
- 2020: 4
- 2021: 5
- 2022: 9
- 2023: 8
- 2024: 6
- 2025: 3
- 2026: 2

## Most-cited predicates
- K211733: Lunit INSIGHT CXR Triage (2021), cited by 6
- K190362: HealthPNX (2019), cited by 6
- K183285: cmTriage (2019), cited by 4
- K191556: Red Dot (2020), cited by 3
- K192320: HealthCXR (2019), cited by 2
- K213319: Viz ANEURYSM, Viz ANX (2022), cited by 2
- K193300: AIMI-Triage CXR PTX (2020), cited by 2
- K213941: Annalise Enterprise CXR Triage Pneumothorax (2022), cited by 2
- K220080: CogNet QmTRIAGE (2022), cited by 2
- K192901: HealthVCF (2020), cited by 2

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