# K960326: FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Mar 7, 1996 after 43 days
- Product code: LMB (Device, Digital Image Storage, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921112 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K921112: Fuji Computed Radiography OD-F623 Optical-Disk, Fujifilm Medical System U.S.A., Inc. (1993) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The subject devices share the intended use of the predicate OD-F623: the storage of FCR image with patient identification data. The subject devices add the additional capability to store image and patient identification data from sources other than computed radiography image readers.

Source page: https://510kreport.com/device/K960326
Methodology: https://510kreport.com/methodology