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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 K193176
Device Name uMR 780
Applicant
Shanghai United Imaging Healthcare Co., Ltd
No. 2258 Chengbei Rd,
Shanghai,  CN 201807
Applicant Contact Xin Gao
Correspondent
Shanghai United Imaging Healthcare Co., Ltd
No. 2258 Chengbei Rd,
Shanghai,  CN 201807
Correspondent Contact Xin Gao
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/18/2019
Decision Date 05/05/2020
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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