# K241505: DRX-Revolution Mobile X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Dec 10, 2024 after 196 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: 3 generations back to K041763 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191025: DRX-Revolution Mobile X-ray System, Carestream Health, Inc. (2019) Summary page 5.

## 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 designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

Source page: https://510kreport.com/device/K241505
Methodology: https://510kreport.com/methodology