Emission Computed Tomography System

System, Tomography, Computed, Emission

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 Emission Computed Tomography System.

Pre-market Notification Details

Device IDK193241
510k NumberK193241
Device Name:Emission Computed Tomography System
ClassificationSystem, Tomography, Computed, Emission
Applicant Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd., Jiading Industrial District Shanghai,  CN 201807
ContactShumei Wang
CorrespondentShumei Wang
Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd., Jiading Industrial District Shanghai,  CN 201807
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-25
Decision Date2020-01-26

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