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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 K183014
Device Name uPMR 790
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
# 2258 Chengbei Rd., Jiading Industrial District
Shanghai,  CN 201807
Applicant Contact Shumei Wang
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
# 2258 Chengbei Rd., Jiading Industrial District
Shanghai,  CN 201807
Correspondent Contact Shumei Wang
Regulation Number892.1200
Classification Product Code
OUO  
Date Received10/31/2018
Decision Date 02/27/2019
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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