# K103596: Wireless/Wired FDR D-Evo Flat Panel Detector

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Mar 29, 2011 after 111 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: 7 generations back to K981556 (1998). 14 ancestors in all.
54 later devices descend from it; 4 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100762: Flat Panel Detector, Model FDR D-Evo, Fujifilm Medical Systems U.S.A, Inc. (2010) Summary page 1.
- K102012: Digital Radiography, Canon Inc. -Medical Equipment Group (2010) Summary page 2.

## Most influential descendants
- K111548: Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE (2011), 52 descendants of its own
- K132509: FDR D-Evo Flat Panel Detector System (2013), 50 descendants of its own
- K141765: FDR D-Evo Flat Panel Detector System (2014), 32 descendants of its own
- K160997: GC85A (2016), 26 descendants of its own
- K163115: GC70 (2016), 23 descendants of its own

## Indications for use
The Wireless/Wired 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 is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Source page: https://510kreport.com/device/K103596
Methodology: https://510kreport.com/methodology