# K150766: Carestream DRX-1 System

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Jun 24, 2015 after 92 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: 3 generations back to K020635 (2002). 3 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130464: Carestream DRX-1 System with DRX 2530C Detector, Carestream Health, Inc. (2013) Summary page 4.

## Most influential descendants
- K162555: Evs 4343, Evs 4343G (2016), 7 descendants of its own
- K192400: Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AG (2019), 6 descendants of its own
- K162552: Evs 3643, Evs 3643G (2016), 3 descendants of its own
- K223124: Expd 86P, Expd 86PG, Expd 129P, Expd 129PG (2022), 2 descendants of its own
- K203159: Lux 35 Detector (2020), 1 descendant 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/K150766
Methodology: https://510kreport.com/methodology