Cleared Special

GXR-Series Diagnostic X-Ray System

K202572 · DRGEM Corporation · Radiology
Sep 2020
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K202572 is an FDA 510(k) clearance for the GXR-Series Diagnostic X-Ray System, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by DRGEM Corporation (Gwangmyeong-Si, KR). The FDA issued a Cleared decision on September 24, 2020, 20 days after receiving the submission on September 4, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K202572 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2020
Decision Date September 24, 2020
Days to Decision 20 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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