Cleared Traditional

DRX-Revolution Mobile X-ray System

K241505 · Carestream Health, Inc. · Radiology
Dec 2024
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K241505 is an FDA 510(k) clearance for the DRX-Revolution Mobile X-ray System, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on December 10, 2024, 196 days after receiving the submission on May 28, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K241505 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2024
Decision Date December 10, 2024
Days to Decision 196 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZL — System, X-ray, Mobile
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1720

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