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 IDK180925
510k NumberK180925
Device Name:UMR 570
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Road., Jiading Industrial District Shanghai,  CN 201807
ContactShumei Wang
CorrespondentShumei Wang
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Road., Jiading Industrial District Shanghai,  CN 201807
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-09
Decision Date2018-06-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06971576830015 K180925 000

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