# QZF: Gastrointestinal Capsule Endoscopy Analysis Software Device

- Device class: 2; regulation: 21 CFR 876.1540; FDA's rule: 510(k) required
- FDA decisions: 3
- 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
- 2026: 2

## Most-cited predicates
- DEN230027: NaviCam ProScan (2023), cited by 2

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