# QHA: X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

- Device class: 2; regulation: 21 CFR 892.1600; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 205 days (middle half 132–255)
- 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: 1
- 2021: 1
- 2023: 2
- 2024: 1
- 2025: 2

## Most-cited predicates
- K210093: AccuFFRangio (2021), cited by 2
- K182611: Qangio XA 3D (2019), cited by 2
- K232147: CAAS Workstation (2024), cited by 1

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