UPMR 790

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Shanghai United Imaging Healthcare Co., Ltd

The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd with the FDA for Upmr 790.

Pre-market Notification Details

Device IDK192672
501k NumberK192672
Device Name:UPMR 790
ClassificationTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Applicant Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd, Shanghai,  CN 201807
ContactXin Gao
CorrespondentXin Gao
Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd, Shanghai,  CN 201807
Product CodeOUO  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2019-11-20

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