# K091889: DRX-Evolution, Model VX3733-Sys

- Pathway: 510(k) (Special)
- Applicant: Carestream Health, Inc.
- Decided: Jul 20, 2009 after 26 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 3 (0 Class I)
- 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.
30 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051258: Kodak Directview DR 7500 System, Model 8791345, Eastman Kodak Company (2005) Summary page 1.
- K090318: Carestream DRX-1 System, Carestream Health, Inc. (2009) Summary page 1.

## Most influential descendants
- K141837: DRX-Evolution (2015), 29 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

## Recalls of this device
- Nov 25, 2013 · Class II · Z-0797-2014: Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
- Nov 25, 2013 · Class II · Z-0796-2014: Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
- Jun 3, 2013 · Class II · Z-1877-2013: Due to potential for an x-ray exposure technique change.

## Indications for use
The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

Source page: https://510kreport.com/device/K091889
Methodology: https://510kreport.com/methodology