Cleared Traditional

GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)

K232178 · DRGEM Corporation · Radiology
Sep 2023
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K232178 is an FDA 510(k) clearance for the GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series), a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by DRGEM Corporation (Gwang-Myeong-Si, KR). The FDA issued a Cleared decision on September 19, 2023, 57 days after receiving the submission on July 24, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K232178 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2023
Decision Date September 19, 2023
Days to Decision 57 days
Submission Type Traditional
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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