UWS-MI

System, Image Processing, Radiological

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 Uws-mi.

Pre-market Notification Details

Device IDK172998
510k NumberK172998
Device Name:UWS-MI
ClassificationSystem, Image Processing, Radiological
Applicant Shanghai United Imaging Healthcare Co.,Ltd. NO.2258 Chengbei Road Shanghai,  CN 201807
ContactShumei Wang
CorrespondentShumei Wang
Shanghai United Imaging Healthcare Co.,Ltd. NO.2258 Chengbei Road Shanghai,  CN 201807
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-27
Decision Date2018-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06971576834037 K172998 000

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