# K152138: FDR D-EVO GL Flat Panel Detector System

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Nov 5, 2015 after 97 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: 11 generations back to K981556 (1998). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142003: FDR D-Evo II Flat Panel Detector System, Fujifilm Medical System U.S.A., Inc. (2014) Summary page 4.
- K101686: FDR Image Stitching Option, Fujifilm Medical System U.S.A., Inc. (2010) Summary page 4.

## Indications for use
The FDR D-EVO GL 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 exams wherever conventional film/screen or CR systems may be used. This device is used to capture anatomic regions that are too large for conventional CR/DR format sizes. FDR D-EVO GL is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Source page: https://510kreport.com/device/K152138
Methodology: https://510kreport.com/methodology