# IZI: System, X-Ray, Angiographic

- Device class: 2; regulation: 21 CFR 892.1600; FDA's rule: 510(k) required
- FDA decisions: 199
- 510(k) review time 2021–2025: median 153 days (middle half 81–264)
- Recalls: 180 (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: 2
- 2018: 2
- 2019: 2
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 3
- 2024: 2
- 2025: 2
- 2026: 2

## Most-cited predicates
- K042961: Spy Intra-Operative Imaging System: SP2000 (2005), cited by 11
- K061871: Leica Model FL800 (2006), cited by 10
- K063345: Spy Imaging System (2007), cited by 8
- K060867: Spy Intraoperative Imaging System (2006), cited by 8
- K984545: Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems (1999), cited by 8
- K071037: Spy Intra-Operative Imaging System, Model SP2000 (2007), cited by 7
- K993763: Quantitative Analysis of Coronary Angiograms (Qca) (1999), cited by 5
- K073088: Spy Fluorescent Imaging System (2008), cited by 5
- K090745: Artis Zee / Zeegos with SW VC14 (2009), cited by 5
- K072222: Spy Fluorescent Imaging System (2007), cited by 5

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