Cleared Traditional

GXR-Series Diagnostic X-Ray System

K242019 · DRGEM Corporation · Radiology
Jan 2025
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K242019 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 January 7, 2025, 181 days after receiving the submission on July 10, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K242019 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2024
Decision Date January 07, 2025
Days to Decision 181 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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