# OWB: Interventional Fluoroscopic X-Ray System

- Device class: 2; regulation: 21 CFR 892.1650; FDA's rule: 510(k) required
- FDA decisions: 325
- 510(k) review time 2021–2025: median 119 days (middle half 54–198)
- Recalls: 262 (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: 20
- 2018: 23
- 2019: 9
- 2020: 16
- 2021: 24
- 2022: 21
- 2023: 12
- 2024: 13
- 2025: 22
- 2026: 15

## Most-cited predicates
- K062623: Axiom Luminos DRF (2007), cited by 10
- K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ (2005), cited by 8
- K993037: LCV+ Version 2 (2000), cited by 6
- K181407: Artis zee/zeego & Artis Q/Q.zen (2018), cited by 6
- K021049: Oec 9800 Plus Digital Mobile Imaging System (2002), cited by 6
- K032761: KMC-950 C-Arm Mobile System (2004), cited by 5
- K033737: Allura Xper FD20 (2003), cited by 5
- K023178: Innova 4100 (2002), cited by 5
- K050489: Innova 2100 (2005), cited by 5
- K132094: Cios Alpha (2014), cited by 5

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