Cleared Traditional

DRX-Rise Mobile X-ray System

K213568 · Carestream Health · Radiology
Mar 2022
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K213568 is an FDA 510(k) clearance for the DRX-Rise 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 23, 2022, 134 days after receiving the submission on November 9, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K213568 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2021
Decision Date March 23, 2022
Days to Decision 134 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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