# K153464: FDR D-EVO flat Panel Detector System

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Apr 8, 2016 after 129 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). 18 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141765: FDR D-Evo Flat Panel Detector System, Fujifilm Medical Systems U.S.A, Inc. (2014) Summary page 4.

## Most influential descendants
- K163624: Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) (2017), 0 descendants of its own
- K170451: FDX Console (DR-ID300CL) Software (2017), 0 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. The FDR D-EVO can be used with Virtual Grid Software, which is optional image processing software installed on Fuyjifilm’s FDX Console. Virtual Grid Software can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.

Source page: https://510kreport.com/device/K153464
Methodology: https://510kreport.com/methodology