UMC 560i

Interventional Fluoroscopic X-ray System

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 Umc 560i.

Pre-market Notification Details

Device IDK183144
510k NumberK183144
Device Name:UMC 560i
ClassificationInterventional Fluoroscopic X-ray System
Applicant Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai,  CN 201807
ContactShumei Wang
CorrespondentGao Xin
Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai,  CN 201807
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-13
Decision Date2019-12-19

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