# QNP: Gastrointesinal Lesion Software Detection System

- Device class: 2; regulation: 21 CFR 876.1520; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 30 days (middle half 28–201)
- 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)
- 2021: 3
- 2022: 1
- 2023: 4
- 2024: 5
- 2025: 5
- 2026: 5

## Most-cited predicates
- DEN200055: GI Genius (2021), cited by 5
- K211951: GI Genius (2021), cited by 3
- K233964: GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) (2024), cited by 2
- K240781: SKOUT® system (2024), cited by 2
- K252178: Magentiq-Colo (ME-Apds) (2025), cited by 1
- K213686: SKOUT Software (2022), cited by 1
- K223473: ME-Apds™; Magentiq-Colo™ (2023), cited by 1
- K230751: EW10-EC02 Endoscopy Support Program (2023), cited by 1
- K241887: GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) (2024), cited by 1
- K252586: Caddie (2025), cited by 1

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