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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 K183292
Device Name Topaz Mobile DR System
Applicant
DRGEM Corporation
7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro
Gwangmyeong-si,  KR 14322
Applicant Contact Ki-Nam Yang
Correspondent
OTech Inc.
8317 Belew Drive
McKinney,  TX  75071
Correspondent Contact Carl Alletto
Regulation Number892.1720
Classification Product Code
IZL  
Date Received11/26/2018
Decision Date 05/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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