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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K192601
Device Name uWS-MR
Applicant
Shanghai United Imaging Healthcare Co., Ltd
No. 2258 Chengbei Rd., Jiading Industrial District
Jiading Industrial District
Shanghai,  CN 201807
Applicant Contact Xin Gao
Correspondent
Shanghai United Imaging Healthcare Co., Ltd
No. 2258 Chengbei Rd., Jiading Industrial District
Jiading Industrial District
Shanghai,  CN 201807
Correspondent Contact Xin Gao
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received09/20/2019
Decision Date 06/01/2020
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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