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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 K190866
Device Name XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
Applicant
Rayence Co., Ltd.
14, Samsung 1-Ro 1-Gil
Hwaseong-Si,  KR 18449
Applicant Contact Kevin Kim
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/03/2019
Decision Date 04/30/2019
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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