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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 K172999
Device Name uWS-MR
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
#2258 Chengbei Rd.,
Shanghai,  CN 201807
Applicant Contact Shumei Wang
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
#2258 Chengbei Rd.,
Shanghai,  CN 201807
Correspondent Contact Shumei Wang
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/27/2017
Decision Date 11/07/2018
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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