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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, Mobile
510(k) Number K242015
Device Name TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
Applicant
DRGEM Corporation
7F, E-B/D Gwangmyeong Techno-Park 60, Haan-ro
GwangMyeong-si,  KR 14322
Applicant Contact Arim Kim
Correspondent
DRGEM Corporation
7F, E-B/D Gwangmyeong Techno-Park 60, Haan-ro
GwangMyeong-si,  KR 14322
Correspondent Contact Arim Kim
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received07/10/2024
Decision Date 12/16/2024
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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