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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 K202156
Device Name DIAMOND-5A/6A/8A
Applicant
DRGEM Corporation
7f, E-B/D Gwangmyeong Techno-Park 60, Haan-Ro
Gwangmyeong-Si,  KR 14322
Applicant Contact Ki-Nam Yang
Correspondent
Otech Lnc.
8317 Belew Dr.
Mckinney,  TX  75071
Correspondent Contact Carl Alletto
Regulation Number892.1680
Classification Product Code
KPR  
Date Received07/27/2020
Decision Date 09/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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