# QAS: Radiological Computer-Assisted Triage And Notification Software

- Device class: 2; regulation: 21 CFR 892.2080; FDA's rule: 510(k) required
- FDA decisions: 89
- 510(k) review time 2021–2025: median 102 days (middle half 58–153)
- 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: 3
- 2019: 5
- 2020: 12
- 2021: 5
- 2022: 15
- 2023: 11
- 2024: 12
- 2025: 15
- 2026: 11

## Most-cited predicates
- K180647: BriefCase (2018), cited by 12
- DEN170073: ContaCT (2018), cited by 10
- K203508: BriefCase (2020), cited by 8
- K190072: BriefCase (2019), cited by 5
- K182177: Accipiolx (2018), cited by 4
- K222884: Rapid NCCT Stroke (2023), cited by 4
- K193658: Viz ICH (2020), cited by 4
- K223042: Viz LVO ContaCT (2022), cited by 3
- K193298: BriefCase (2020), cited by 3
- K211179: InferRead CT Stroke.AI (2021), cited by 2

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