# K100762: Flat Panel Detector, Model FDR D-Evo

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jul 15, 2010 after 120 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: 2 generations back to K020635 (2002). 3 ancestors in all.
55 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090318: Carestream DRX-1 System, Carestream Health, Inc. (2009). Our OCR of the scanned summary read K080318, FDA’s number for Alma Laser Nir Module (Alma Lasers, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Carestream DRX-1”.
- K042023: Fuji Computed Radiography (FCR) Clearview CS Image Reader, Fujifilm Medical System U.S.A., Inc. (2004) Summary page 2.
- (no number) Canon CXDI-55G detector: named in the summary without a submission number

## Most influential descendants
- K103596: Wireless/Wired FDR D-Evo Flat Panel Detector (2011), 54 descendants of its own
- 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

## Indications for use
The FOR 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, tomegraphy, and angiography applications.

Source page: https://510kreport.com/device/K100762
Methodology: https://510kreport.com/methodology