# IZW: Collimator, Automatic, Radiographic

- Device class: 2; regulation: 21 CFR 892.1610; FDA's rule: 510(k) exempt
- FDA decisions: 23
- Recalls: 3 (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)
- 1995: 1
- 1996: 1
- 1998: 1
- 1999: 1
- 2003: 1
- 2005: 1
- 2007: 2
- 2008: 1
- 2009: 2
- 2010: 2

## Most-cited predicates
- K050092: R605 Facs Collimeter (2005), cited by 3
- K031597: Dunlee Format Collimator Family (2003), cited by 2
- K072780: Model R302DACS/a Automatic X-Ray Collimator (2007), cited by 2
- K990423: Philips Nicol Collimator Family (1999), cited by 1
- K810598: X-Ray Collimating Devices (1981), cited by 1

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