# K970293: Fuji Computed Radiography FCR/Dicom Gateway Unit CR-DM666

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Mar 21, 1997 after 56 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921112 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960326: FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System, Fujifilm Medical System U.S.A., Inc. (1996) Summary page 1.

## Indications for use
The indications for use of the FCR/DICOM Gateway Unit CR-DM666 is to serve as a gateway between a proprietary FCR DMS network and a standard ACR/NEMA Digital Imaging and Communications (DICOM) network.

Source page: https://510kreport.com/device/K970293
Methodology: https://510kreport.com/methodology