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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 K192672
Device Name uPMR 790
Applicant
Shanghai United Imaging Healthcare Co., Ltd
No. 2258 Chengbei Rd,
Shanghai,  CN 201807
Applicant Contact Xin Gao
Correspondent
Shanghai United Imaging Healthcare Co., Ltd
No. 2258 Chengbei Rd,
Shanghai,  CN 201807
Correspondent Contact Xin Gao
Regulation Number892.1200
Classification Product Code
OUO  
Date Received09/26/2019
Decision Date 11/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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