# K033561: Fuji Computed Radiography (FCR) Velocity Image Reader

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Nov 26, 2003 after 14 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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
Longest line of descent: 1 generation back to K951373 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951373: Fuji Computed Radiography System FCR9000HQ, FCR9501HQ, Fujifilm Medical System U.S.A., Inc. (1995) Summary page 2.

## Most influential descendants
- K073650: Fujifilm Unity Speedsuite, Model CR-IR 371 (2008), 0 descendants of its own

## Indications for use
The indications for use of the Fuji Computed Radiography (FCR) Velocity Image Reader with Image Plate (IP) reading is the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.

Source page: https://510kreport.com/device/K033561
Methodology: https://510kreport.com/methodology