# JAA: System, X-Ray, Fluoroscopic, Image-Intensified

- Device class: 2; regulation: 21 CFR 892.1650; FDA's rule: 510(k) required
- FDA decisions: 300
- 510(k) review time 2021–2025: median 92 days (middle half 29–116)
- Recalls: 163 (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: 1
- 2018: 3
- 2019: 6
- 2020: 4
- 2021: 6
- 2022: 1
- 2023: 2
- 2024: 3
- 2025: 2
- 2026: 1

## Most-cited predicates
- K021021: Modular Angiography System Axiom Artis (2002), cited by 5
- K101491: Uroskop Omnia (2010), cited by 4
- K130318: Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB) (2013), cited by 4
- K024012: Oec 9800 E/CV+ Digital Mobile Imaging System (2003), cited by 4
- K914525: Flurospot H Version 2 (1991), cited by 3
- K945460: Philips CD Medical Recorder, View Station, Dup[[Lication Station (1995), cited by 3
- K912470: Philips Diagnost 96 (1991), cited by 3
- K132904: Ziehm Vision RFD (2013), cited by 3
- K182834: CS-series-FP with Optional ROI Accessory CA-100S (2019), cited by 3
- K190373: SonialVision G4 (2019), cited by 3

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