# IXW: Processor, Radiographic-Film, Automatic

- Device class: 2; regulation: 21 CFR 892.1900; FDA's rule: 510(k) exempt
- FDA decisions: 83
- Recalls: 0 (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)
- 1996: 2
- 1997: 2
- 1998: 1
- 1999: 3
- 2000: 3
- 2002: 1
- 2003: 4
- 2009: 1
- 2010: 1
- 2011: 1

## Most-cited predicates
- K951373: Fuji Computed Radiography System FCR9000HQ, FCR9501HQ (1995), cited by 5
- K954345: Doosan DSP 3800 Automatic X-Ray Film Processor (1995), cited by 2
- K944046: Fuji Computed Radiography Systems (1995), cited by 2
- K992818: Optimax/ Compact 2 (1999), cited by 2
- K940112: X-Ray Film Processor (1995), cited by 1
- K880565: 3M Trimatic M Modular System and Accessories (1988), cited by 1
- K905607: Kodak X-Omat Multiloader 300 (1991), cited by 1
- K093503: Intrax Film Processor (2010), cited by 1
- K880563: 3M XP515 X-Ray Film Processor (1988), cited by 1

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