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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 K200024
Device Name uMR 570
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 Received01/06/2020
Decision Date 04/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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