# IZF: System, X-Ray, Tomographic

- Device class: 2; regulation: 21 CFR 892.1740; FDA's rule: 510(k) required
- FDA decisions: 42
- 510(k) review time 2021–2025: median 118 days (middle half 53–184)
- Recalls: 2 (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)
- 2002: 1
- 2012: 1
- 2013: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2023: 2
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K132261: Discovery XR656 with Volumerad (Digital Tomosynthesis) (2013), cited by 4
- K183275: DR 800 with Tomosynthesis (2019), cited by 3
- K121499: Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System (2012), cited by 2
- K250850: Nanox.ARC X (2025), cited by 1
- K221949: Ortho Device, ADAPTIX 3D Orthopedic Imaging System (2023), cited by 1
- K242395: Nanox.ARC (2024), cited by 1
- K884650: Resubmitted Scanora (1989), cited by 1
- K222934: Nanox.ARC (2023), cited by 1
- K925302: Philips Integris H/HM System (1992), cited by 1
- K944967: Tomo-Link (1994), cited by 1

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