NeuSight PET/CT Scanner System

GUDID 06970167440060

Neusoft Medical Systems Co., Ltd.

PET/CT system
Primary Device ID06970167440060
NIH Device Record Keye4ebd2a0-6406-493b-b1c3-e9eb97adbb62
Commercial Distribution Discontinuation2017-02-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNeuSight PET/CT Scanner System
Version Model NumberNeuSight PET/CT 16
Company DUNS724421537
Company NameNeusoft Medical Systems 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970167440060 [Primary]

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-19

On-Brand Devices [NeuSight PET/CT Scanner System]

06970167440060NeuSight PET/CT 16
06970167440053NeuSight PET/CT 64

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