UMI 780 PET/CT 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 Umi 780 Pet/ct System.

Pre-market Notification Details

Device IDK172143
510k NumberK172143
Device Name:UMI 780 PET/CT System
ClassificationSystem, Tomography, Computed, Emission
Applicant Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Road,Jiading District Shanghai,  CN 201807
ContactShumei Wang
CorrespondentShumei Wang
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Road,Jiading District Shanghai,  CN 201807
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-17
Decision Date2018-04-13
Summary:summary

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