# K153142: Carestream DRX-1 System with DRX Plus 4343 Detectors

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Nov 25, 2015 after 26 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: 4 generations back to K020635 (2002). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150766: Carestream DRX-1 System, Carestream Health, Inc. (2015) Summary page 4.

## Most influential descendants
- K253185: Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (2026), 0 descendants of its own

## Indications for use
The device is intended to capture for display radiographic images of human anatomy including both pediatric and adult patients. The device 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, and angiography applications.

Source page: https://510kreport.com/device/K153142
Methodology: https://510kreport.com/methodology