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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 K181626
Device Name Digital Diagnostic Mobile X-ray System
Applicant
Samsung Electronics Co., Ltd.
129 Samsung-Ro, Yeongtong-Gu
Suwon-Si,  KR 16677
Applicant Contact Chang Soeun
Correspondent
Samsung Electronics Co., Ltd.
129 Samsung-Ro, Yeongtong-Gu
Suwon-Si,  KR 16677
Correspondent Contact Chang Soeun
Regulation Number892.1720
Classification Product Code
IZL  
Date Received06/20/2018
Decision Date 07/20/2018
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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