UDR 592h, UDR 596i

System, X-ray, Stationary

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 Udr 592h, Udr 596i.

Pre-market Notification Details

Device IDK181413
510k NumberK181413
Device Name:UDR 592h, UDR 596i
ClassificationSystem, X-ray, Stationary
Applicant Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai,  CN 201807
ContactShumei Wang
CorrespondentShumei Wang
Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai,  CN 201807
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-30
Decision Date2018-06-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06971576833023 K181413 000

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