Cleared Traditional

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

K250954 · Carestream Health · Radiology

Jan 2026

Decision

298d

Days

Class 2

Risk

About This 510(k) Submission

K250954 is an FDA 510(k) clearance for the DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Carestream Health (Rochester, US). The FDA issued a Cleared decision on January 20, 2026, 298 days after receiving the submission on March 28, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K250954 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2025
Decision Date	January 20, 2026
Days to Decision	298 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF