# IXK: System, Imaging, X-Ray, Electrostatic

- Device class: 2; regulation: 21 CFR 892.1630; FDA's rule: 510(k) required
- FDA decisions: 14
- 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)
- 1985: 1
- 1992: 3
- 1993: 1
- 1994: 2
- 2000: 1
- 2002: 1
- 2003: 1
- 2004: 1
- 2007: 1
- 2011: 1

## Most-cited predicates
- K934949: Digora (1994), cited by 5
- K924459: Digiscan 2 (1992), cited by 3
- K003689: Canon X-Ray Digital Camera, Model Cxdi-31 (2002), cited by 3
- K032654: Port Cassette (2003), cited by 2
- K923990: Fuji Computed Radiography HI-C652B DMS CRT Image (1992), cited by 1
- K931002: Fuji Computed Radiograp HI-C654 DMS CRT Image Cons (1993), cited by 1
- K924012: Fuji Computed Radiography HI-C653 DMS CRT Image (1992), cited by 1
- K000159: Agfa Diagnostic Center Adc, Adc Compact, and Adc Solo (2000), cited by 1
- K042779: Radiotherapy Solution Based on CR (2004), cited by 1

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