uMI

GUDID 06971576832057

Shanghai United Imaging Healthcare Co., Ltd.

PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system
Primary Device ID06971576832057
NIH Device Record Keyac49e4b5-5178-4ef8-b4c0-32669767d8fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameuMI
Version Model NumberuMI 550
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
GS106971576832057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPSSystem, Tomography, Computed, Emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-17
Device Publish Date2020-07-09

On-Brand Devices [uMI]

06971576832026Positron Emission Tomography and Computed Tomography System
06971576832057uMI 550
06971576832170uMI Panorama 35
06971576832187uMI Panorama GS

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