UMR Omega With UWS-MR-MRS

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 Omega With Uws-mr-mrs.

Pre-market Notification Details

Device IDK220332
510k NumberK220332
Device Name:UMR Omega With UWS-MR-MRS
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Shanghai United Imaging Healthcare Co.,Ltd. NO.2258 Chengbei Road, Jiading District Shanghai,  CN 201807
ContactXin Gao
CorrespondentXin Gao
Shanghai United Imaging Healthcare Co.,Ltd. NO.2258 Chengbei Road, Jiading District Shanghai,  CN 201807
Product CodeLNH  
Subsequent Product CodeLLZ
Subsequent Product CodeQIH
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-04
Decision Date2022-10-27

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