Cleared Traditional

GXR-Series Diagnostic X-Ray System

K192364 · DRGEM Corporation · Radiology
Sep 2019
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K192364 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 26, 2019, 27 days after receiving the submission on August 30, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K192364 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2019
Decision Date September 26, 2019
Days to Decision 27 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

Similar Devices — KPR System, X-ray, Stationary

All 353
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
K250954 · Carestream Health · Jan 2026
uDR Arria & uDR Aris
K252000 · Shanghai United Imaging Healthcare Co., Ltd. · Nov 2025
uDR Aurora CX
K251167 · Shanghai United Imaging Healthcare Co., Ltd. · Sep 2025
Definium Tempo Select
K250788 · Ge Hualun Medical Systems Co. , Ltd. · Aug 2025
INNOVISION-DXII
K250790 · Dk Medical Systems Co., Ltd. · Aug 2025
YSIO X.pree
K250738 · Siemens Medical Solutions · Jul 2025