# K191025: DRX-Revolution Mobile X-ray System

- Pathway: 510(k) (Special)
- Applicant: Carestream Health, Inc.
- Decided: May 17, 2019 after 29 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K041763 (2004). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120062: DRX-Revolution Mobile X-Ray System, Carestream Health, Inc. (2012) Summary page 4.

## Most influential descendants
- K241505: DRX-Revolution Mobile X-ray System (2024), 1 descendant of its own
- K222339: uDR 380i Pro (2022), 1 descendant of its own
- K253185: Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (2026), 0 descendants of its own
- K242515: uDR 380i Pro (2024), 0 descendants of its own
- K213568: DRX-Rise Mobile X-ray System (2022), 0 descendants of its own

## Recalls of this device
- Oct 2, 2023 · Class II · Z-0289-2024: There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary
- Oct 2, 2023 · Class II · Z-0437-2024: Unexpected failure of electrical components within the CPI generator.

## 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/K191025
Methodology: https://510kreport.com/methodology