# K944046: Fuji Computed Radiography Systems

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: May 11, 1995 after 266 days
- Product code: IXW (Processor, Radiographic-Film, Automatic)
- Device class: 2
- Regulation: 21 CFR 892.1900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
84 later devices descend from it; 2 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K993861: Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side Reader (2000), 82 descendants of its own
- K024147: Paxscan 4030 Medical Digital Imaging System (2003), 78 descendants of its own
- K092669: DX-D Imaging Package (2009), 34 descendants of its own
- K120020: Vivix-S (2012), 30 descendants of its own
- K122865: Vivix-S Wireless (2013), 28 descendants of its own

## Recalls of this device
- Apr 1, 2016 · Class II · Z-1599-2016: Reports of failure of the device's power supply.

Source page: https://510kreport.com/device/K944046
Methodology: https://510kreport.com/methodology