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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K160579
Device Name Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
Applicant
Rayence Co., Ltd.
14, Samsung 1-Ro, 1-Gil
Hwaseong-Si,  KR 445-170
Applicant Contact Kevin Kim
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact DAVE KIM
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/01/2016
Decision Date 04/08/2016
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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