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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 K230152
Device Name uMR Omega
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
No.2258 Chengbei Road, Jiading District
Shanghai,  CN 201807
Applicant Contact Xin Gao
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
No.2258 Chengbei Road, Jiading District
Shanghai,  CN 201807
Correspondent Contact Xin Gao
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/19/2023
Decision Date 05/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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