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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K242019
Device Name GXR-Series Diagnostic X-Ray System
Applicant
DRGEM Corporation
7F, E-B/D Gwangmyeong Techno-Park, 60Haan-ro,
GwangMyeong-si,  KR 14322
Applicant Contact Jongseon Park
Correspondent
DRGEM Corporation
7F, E-B/D Gwangmyeong Techno-Park, 60Haan-ro,
GwangMyeong-si,  KR 14322
Correspondent Contact Jongseon Park
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received07/10/2024
Decision Date 01/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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