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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 K160997
Device Name GC85A
Applicant
Samsung Electronics Co., Ltd.
129, Samsung-Ro
Yeongtong-Gu
Suwon-Si,,  KR 443-742
Applicant Contact CHULSIN KIM
Correspondent
Samsung Electronics Co., Ltd.
129, Samsung-Ro
Yeongtong-Gu
Suwon-Si,,  KR 443-742
Correspondent Contact CHULSIN KIM
Regulation Number892.1680
Classification Product Code
KPR  
Date Received04/11/2016
Decision Date 07/06/2016
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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