# IZX: Collimator, Manual, Radiographic

- Device class: 2; regulation: 21 CFR 892.1610; FDA's rule: 510(k) exempt
- FDA decisions: 17
- Recalls: 4 (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)
- 1987: 1
- 1990: 2
- 1991: 1
- 1993: 1
- 1997: 2
- 1998: 1
- 2003: 1
- 2004: 1
- 2010: 1
- 2011: 1

## Most-cited predicates
- K031771: Shimadzu Collimator R-30H (2003), cited by 2
- K981267: Facts Monoblock (1998), cited by 1
- K972966: Axt 150M Manual Collimator (Axt 150M) (1997), cited by 1

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