# K250954: DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health
- Decided: Jan 20, 2026 after 298 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 17 generations back to K981556 (1998). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243556: Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43), Iray Imaging Technology (Haining) Limited (2025) Summary page 5.
- K233381: DRX-Evolution Plus System, Carestream Health, Inc. (2024) Summary page 5.
- K223842: DRX - Compass, Carestream Health, Inc. (2023) Summary page 5.

## Indications for use
DRX-Evolution Plus X-ray System The device is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography. DRX-Compass X-ray System The device is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen, and other body parts. The device is not indicated for use in mammography. 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.

Source page: https://510kreport.com/device/K250954
Methodology: https://510kreport.com/methodology