# MUJ: System, Planning, Radiation Therapy Treatment

- Device class: 2; regulation: 21 CFR 892.5050; FDA's rule: 510(k) required
- FDA decisions: 258
- 510(k) review time 2021–2025: median 134 days (middle half 97–210)
- Recalls: 131 (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: 7
- 2018: 7
- 2019: 9
- 2020: 9
- 2021: 11
- 2022: 8
- 2023: 10
- 2024: 9
- 2025: 10
- 2026: 9

## Most-cited predicates
- K992762: Brachyvision 6.0 (2000), cited by 7
- K101119: Syngo Dosimetrist Workspace V2.7 Model: 1056864 (2010), cited by 6
- K983343: Plato Brachytheraphy, Model V. 14.0 (1999), cited by 6
- K080601: Ergo++ Version 1.7 (2008), cited by 6
- K102011: Eclipse Treatment Planning System (2010), cited by 5
- K993923: Adac PINNACLE3TM Radiation Therapy Planning System (2000), cited by 5
- K002237: P3IMRT TM (2001), cited by 5
- K081281: Ocentra Masterplan 3.1 (Ocentra Brachy) (2008), cited by 5
- K181145: Eclipse Treatment Planning System (2018), cited by 5
- K091492: Modification to Eclipse Treatment Planning System (2009), cited by 4

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