# K921112: Fuji Computed Radiography OD-F623 Optical-Disk

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Apr 27, 1993 after 414 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K960326: FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System (1996), 2 descendants of its own
- K980243: Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis) (1998), 0 descendants of its own
- K970293: Fuji Computed Radiography FCR/Dicom Gateway Unit CR-DM666 (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K921112
Methodology: https://510kreport.com/methodology