HYPER Focus

System, Tomography, Computed, Emission

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 Hyper Focus.

Pre-market Notification Details

Device IDK210418
510k NumberK210418
Device Name:HYPER Focus
ClassificationSystem, Tomography, Computed, Emission
Applicant Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai,  CN 201807
ContactXin Gao
CorrespondentXin Gao
Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai,  CN 201807
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-11
Decision Date2021-04-09

Trademark Results [HYPER Focus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYPER FOCUS
HYPER FOCUS
90706060 not registered Live/Pending
Shanghai United Imaging Healthcare Co.,Ltd.
2021-05-12

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