# K132509: FDR D-Evo Flat Panel Detector System

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Nov 25, 2013 after 105 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: 9 generations back to K981556 (1998). 16 ancestors in all.
50 later devices descend from it; 3 cite it directly.
0 of 67 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.
- K111548: Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE, Fujifilm Medical System U.S.A., Inc. (2011)

## Most influential descendants
- 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
- K162278: Digital Diagnostic Mobile X-ray System (2016), 23 descendants of its own
- K171119: GM85 (2017), 22 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 including pediatric and, neonatal exams 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/K132509
Methodology: https://510kreport.com/methodology