# K081308: Fujifilm FCR View, Model CR-VW674

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jun 4, 2008 after 26 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K041990 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041990: Fuji Medical CR Console, Model Flash Iip, Fujifilm Medical System U.S.A., Inc. (2004) Summary page 3.
- (no number) FCR Axon: named in the summary without a submission number

## Indications for use
FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.

Source page: https://510kreport.com/device/K081308
Methodology: https://510kreport.com/methodology