# K253185: Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health
- Decided: Mar 11, 2026 after 166 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K020635 (2002). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241505: DRX-Revolution Mobile X-ray System, Carestream Health, Inc. (2024) Summary page 6.
- K153142: Carestream DRX-1 System with DRX Plus 4343 Detectors, Carestream Health, Inc. (2015) Summary page 8.
- K183245: Carestream DRX-1 System with DRX Plus 2530 Detectors, Carestream Health, Inc. (2019) Summary page 8.
- K203159: Lux 35 Detector, Carestream Health (2020) Summary page 8.
- (no number) Lux HD Detectors: named in the summary without a submission number

## Indications for use
DRX-Revolution Mobile X-ray System The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas. Lux HD Detectors Lux HD 35 Detector and Lux HD 43 Detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general–purpose diagnostic procedures. Lux HD 35 Detector and Lux HD 43 Detector are not intended for mammography or dental applications. DRX-LC Detector DRX-LC, as a major imaging component, are supplied to the manufacturers of medical diagnostic X-ray photography systems and used in conjunction with the medical diagnostic X-ray photography system to image the object to be checked. They are capable of outputting the acquired static images to a processing device after acquisition.

Source page: https://510kreport.com/device/K253185
Methodology: https://510kreport.com/methodology