uEXPLORER

GUDID 06971576832040

Positron Emission Tomography and Computed Tomography System

Shanghai United Imaging Healthcare Co., Ltd.

PET/CT system
Primary Device ID06971576832040
NIH Device Record Key7a0ad3ee-2f90-4625-9b5a-82f9f181cf26
Commercial Distribution StatusIn Commercial Distribution
Brand NameuEXPLORER
Version Model NumberuEXPLORER
Company DUNS421271328
Company NameShanghai United Imaging Healthcare Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971576832040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-08
Device Publish Date2019-03-29

Devices Manufactured by Shanghai United Imaging Healthcare Co., Ltd.

06971576830435 - uMR2024-08-08
06971576830084 - uPMR2023-10-16
06971576831050 - uCT2023-10-16 Computed Tomography X-ray System
06971576833061 - uDR2023-10-16 Digital Medical X-ray Imaging System
06971576830107 - uMR2023-09-29
06971576832187 - uMI2023-09-29
06971576832170 - uMI2023-03-28
06971576831340 - uCT2023-03-08

Trademark Results [uEXPLORER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UEXPLORER
UEXPLORER
87695852 not registered Live/Pending
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
2017-11-23

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