# MYN: Analyzer, Medical Image

- Device class: 2; regulation: 21 CFR 892.2070; FDA's rule: 510(k) required
- FDA decisions: 51
- 510(k) review time 2021–2025: median 241 days (middle half 146–270)
- Recalls: 2 (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)
- 2015: 3
- 2016: 2
- 2017: 3
- 2019: 1
- 2021: 2
- 2022: 5
- 2023: 10
- 2024: 2
- 2025: 14
- 2026: 7

## Most-cited predicates
- K210365: Second Opinion (2022), cited by 9
- K222746: Overjet Caries Assist (2023), cited by 7
- K210666: Chest-CAD (2021), cited by 5
- P980025: Logicon Caries Detector (1998), cited by 4
- K201560: Auto Lung Nodule Detection (2021), cited by 3
- K232384: Videa Dental Assist (2023), cited by 2
- K231678: Overjet Periapical Radiolucency Assist (2023), cited by 2
- K240003: Velmeni for Dentists (V4D) (2024), cited by 2
- K221921: DTX Studio Clinic 3.0 (2023), cited by 2
- K212519: Overjet Caries Assist (2022), cited by 2

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