# K052661: Quix Digital Radiographic Upgrade

- Pathway: 510(k) (Traditional)
- Applicant: Edge Medical Devices, Ltd.
- Decided: Jun 7, 2006 after 253 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: 4 generations back to K803130 (1981). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993861: Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side Reader, Fujifilm Medical System U.S.A., Inc. (2000) Summary page 1.
- K992794: Stingray DR, Model 1, Infimed, Inc. (1999) Summary page 1.
- (no number) AGFA CP-B 200 screen / AGFA CP-BU New film: named in the summary without a submission number

## Indications for use
The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.

Source page: https://510kreport.com/device/K052661
Methodology: https://510kreport.com/methodology