# QQE: Image Management Software For Planning Of Otologic And Neurotologic Procedures

- Device class: 2; regulation: 21 CFR 892.2050; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 266 days (middle half 204–266)
- 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: 1
- 2022: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K203486: Otoplan (2021), cited by 2

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