# MWP: Cabinet, X-Ray System

- Device class: 2; regulation: 21 CFR 892.1680; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 125 days (middle half 96–154)
- 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)
- 2010: 1
- 2011: 1
- 2012: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2019: 5
- 2020: 2
- 2021: 4
- 2023: 2

## Most-cited predicates
- K111508: Trident Specimen Radiography System, Model : RC Tri-00001 (2011), cited by 6
- K071233: Xpert 40 Specimen Radiography System (2007), cited by 5
- K052433: Pixarray 100 Digital Specimen Radiography (DSR) System (2005), cited by 4
- K091558: Biovision Digital Specimen Radiography System (2009), cited by 4
- K061361: Faxitron Digital Radiography System, Model DX-50 (2006), cited by 3
- K122428: Faxitron Specien Radiography System (2012), cited by 2
- K202713: TrueView 100 Pro (2020), cited by 2
- K153583: BioVision Plus (2016), cited by 2
- K021113: Mammopath (2002), cited by 2
- K183624: Kubtec Mozart (Xpert42) (2019), cited by 2

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