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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 K240540
Device Name uMR Omega
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd. Jiading District
Shanghai,  CN 201807
Applicant Contact Xin Gao
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd. Jiading District
Shanghai,  CN 201807
Correspondent Contact Xin Gao
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received02/26/2024
Decision Date 03/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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