# K141837: DRX-Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Mar 11, 2015 after 247 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K020635 (2002). 4 ancestors in all.
29 later devices descend from it; 3 cite 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)
- K091889: DRX-Evolution, Model VX3733-Sys, Carestream Health, Inc. (2009) Summary page 4.

## Most influential descendants
- 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
- K172229: GC85A (2017), 21 descendants of its own

## Recalls of this device
- Aug 7, 2015 · Class II · Z-2449-2015: Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.

## Indications for use
The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

Source page: https://510kreport.com/device/K141837
Methodology: https://510kreport.com/methodology