UMR 570

System, Nuclear Magnetic Resonance Imaging

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 Umr 570.

Pre-market Notification Details

Device IDK200024
510k NumberK200024
Device Name:UMR 570
ClassificationSystem, Nuclear Magnetic Resonance Imaging
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 CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-06
Decision Date2020-04-20

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