Cleared Traditional

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

K253185 · Carestream Health · Radiology

Mar 2026

Decision

166d

Days

Class 2

Risk

About This 510(k) Submission

K253185 is an FDA 510(k) clearance for the Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Carestream Health (Rochester, US). The FDA issued a Cleared decision on March 11, 2026, 166 days after receiving the submission on September 26, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K253185 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2025
Decision Date	March 11, 2026
Days to Decision	166 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF