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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
510(k) Number K261676
Device Name uPMR Zenith
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
#2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Shanghai,  CN 201807
Applicant Contact GAO Xin
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
#2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Shanghai,  CN 201807
Correspondent Contact Xin Gao
Regulation Number892.1200
Classification Product Code
OUO  
Subsequent Product Code
MOS  
Date Received05/21/2026
Decision Date 10/28/2026
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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