# OXO: Image-Intensified Fluoroscopic X-Ray System, Mobile

- Device class: 2; regulation: 21 CFR 892.1650; FDA's rule: 510(k) required
- FDA decisions: 82
- 510(k) review time 2021–2025: median 119 days (middle half 66–155)
- Recalls: 34 (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)
- 2014: 2
- 2015: 1
- 2016: 3
- 2017: 4
- 2018: 1
- 2019: 3
- 2021: 2
- 2024: 2
- 2025: 4
- 2026: 2

## Most-cited predicates
- K003266: Siremobil Iso-C 3D (2000), cited by 7
- K973598: Siremobil CO2 (1997), cited by 7
- K113708: Orthoscan Mobile DI Mini C-Arm (2012), cited by 4
- K120613: Oec 9900 Elite (2012), cited by 3
- K003837: Flexiview 8800 Digital Mobile Imaging System (2001), cited by 3
- K040066: Siremobile C06 (2004), cited by 3
- K040347: Siremobil Iso-C 3D (2004), cited by 3
- K051133: Arcadis Avantic (2005), cited by 3
- K050996: O-Arm Imaging System (2005), cited by 3
- K213113: Orthoscan Tau Mini C-Arm (2021), cited by 2

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