# K090318: Carestream DRX-1 System

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Apr 6, 2009 after 56 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020635 (2002). 1 ancestor in all.
79 later devices descend from it; 4 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020635: Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900 System, Catalog# 1170976, Eastman Kodak Company (2002) Summary page 1.

## Most influential descendants
- K100762: Flat Panel Detector, Model FDR D-Evo (2010), 55 descendants of its own
- 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

## Recalls of this device
- Aug 29, 2013 · Class II · Z-0180-2014: Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable System
- Jun 12, 2012 · Class II · Z-2202-2012: Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.

## Indications for use
The Carestream DRX-1 System is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. Excluded from the indications for use are mammography, fluoroscopy, tomography and angiography applications.

Source page: https://510kreport.com/device/K090318
Methodology: https://510kreport.com/methodology