# K111865: Wired/ Wireless FDR D-Evo with X-Ray Detection Feature

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Sep 30, 2011 after 92 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: 8 generations back to K981556 (1998). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103596: Wireless/Wired FDR D-Evo Flat Panel Detector, Fujifilm Medical Systems U.S.A, Inc. (2011) Summary page 2.

## Indications for use
The Wired/Wireless FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The FDR D-EVO (DR-ID 600) is not intended for mammography, fluoroscopy, tomography and angiography applications.

Source page: https://510kreport.com/device/K111865
Methodology: https://510kreport.com/methodology