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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 K171977
Device Name miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
Applicant
Hinacom Software and Technology, Ltd.
Suite B301, R&D Plaza, Tsinghua Science Park, Haidian Distr.
Beijing,  CN 100084
Applicant Contact Yi Isabelle Sun
Correspondent
Hinacom Software and Technology, Ltd.
Suite B301, R&D Plaza, Tsinghua Science Park, Haidian Distr.
Beijing,  CN 100084
Correspondent Contact Yi Isabelle Sun
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/30/2017
Decision Date 08/02/2018
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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