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 IDK192630
510k NumberK192630
Device Name:UWS-MI
ClassificationSystem, Image Processing, Radiological
Applicant Shanghai United Imaging Healthcare Co., Ltd. NO. 2258 Chengbei Road Shanghai,  CN 201807
ContactXin Gao
CorrespondentXin Gao
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 Received2019-09-23
Decision Date2020-06-11

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