UMR 780

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 780.

Pre-market Notification Details

Device IDK193176
510k NumberK193176
Device Name:UMR 780
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd, Shanghai,  CN 201807
ContactXin Gao
CorrespondentXin Gao
Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd, Shanghai,  CN 201807
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-18
Decision Date2020-05-05

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.