UCT ATLAS With UWS-CT-Dual Energy Analysis

System, X-ray, Tomography, Computed

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 Uct Atlas With Uws-ct-dual Energy Analysis.

Pre-market Notification Details

Device IDK203448
510k NumberK203448
Device Name:UCT ATLAS With UWS-CT-Dual Energy Analysis
ClassificationSystem, X-ray, Tomography, Computed
Applicant Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengei Rd., Jiading Industrial District Shanghai,  CN 201807
ContactXin Gao
CorrespondentXin Gao
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengei Rd., Jiading Industrial District Shanghai,  CN 201807
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-08-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06971576831104 K203448 000
06971576834150 K203448 000

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