# IZL: System, X-Ray, Mobile

- Device class: 2; regulation: 21 CFR 892.1720; FDA's rule: 510(k) required
- FDA decisions: 238
- 510(k) review time 2021–2025: median 96 days (middle half 53–161)
- Recalls: 122 (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: 8
- 2019: 9
- 2020: 9
- 2021: 13
- 2022: 16
- 2023: 3
- 2024: 9
- 2025: 11
- 2026: 6

## Most-cited predicates
- K182207: TR90BH (2018), cited by 9
- K040046: Minxray, Model HF120/60H Powerplus (2004), cited by 5
- K120062: DRX-Revolution Mobile X-Ray System (2012), cited by 5
- K161345: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR (2016), cited by 5
- K052721: Minxray, Model HF100H+ (2005), cited by 5
- K192011: PhoeniX (2019), cited by 4
- K090322: Easy Moving Plus, SM-XXHF-YY (2009), cited by 4
- K021016: Amx-4 Plus Mobile X-Ray System (2002), cited by 4
- K171119: GM85 (2017), cited by 4
- K191025: DRX-Revolution Mobile X-ray System (2019), cited by 3

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