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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K201540
Device Name uMR570
Applicant
Shanghai United Imaging Healthcare Co.,Ltd.
NO.2258 Chengbei Road,
Shanghai,  CN 201807
Applicant Contact Xin GAO
Correspondent
Shanghai United Imaging Healthcare Co.,Ltd.
NO.2258 Chengbei Road,
Shanghai,  CN 201807
Correspondent Contact Xin GAO
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/09/2020
Decision Date 07/06/2020
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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