# MUE: Full Field Digital, System, X-Ray, Mammographic

- Device class: 2; regulation: 21 CFR 892.1715; FDA's rule: 510(k) required
- FDA decisions: 62
- 510(k) review time 2021–2025: median 263 days (middle half 130–387)
- Recalls: 27 (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)
- 2017: 8
- 2018: 2
- 2019: 2
- 2020: 4
- 2021: 4
- 2022: 3
- 2023: 1
- 2024: 1
- 2025: 3
- 2026: 4

## Most-cited predicates
- P030010: Siemens Mammomat Novationdr Full Field Digital Mammography System (2004), cited by 6
- P990066: GE Healthcare Senographe Full Field Digital Mammography System (2000), cited by 6
- P050014: Fuji's Computed Radiography  Mammography Suite (Fcrms) (2006), cited by 3
- K193166: MAMMOMAT Revelation (2020), cited by 3
- K173576: Pristina Serena (2018), cited by 2
- K110025: Sectra Microdose Mammography (2011), cited by 2
- K162268: Senographe Pristina (2016), cited by 2
- K163328: Planmed Clarity (2017), cited by 2
- K103485: Senograph DS, Senograph Essenstial (2011), cited by 2
- K173408: Mammomat Revelation (2018), cited by 2

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