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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 K222755
Device Name uMR 680
Applicant
Shanghai United Imaging Intelligence Co., Ltd.
No. 2258 Chengbei Road, Jiading District
Shanghai,  CN 201807
Applicant Contact Xin GAO
Correspondent
Shanghai United Imaging Intelligence Co., Ltd.
No. 2258 Chengbei Road, Jiading District
Shanghai,  CN 201807
Correspondent Contact Xin GAO
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/12/2022
Decision Date 02/16/2023
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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