NeuViz Prime Multi-Slice CT Scanner System

GUDID 06970167440077

Neusoft Medical Systems Co., Ltd.

Full-body CT system
Primary Device ID06970167440077
NIH Device Record Key36fc442b-be0a-478a-84f4-7b3160261bb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuViz Prime Multi-Slice CT Scanner System
Version Model NumberNeuViz Prime
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
GS106970167440077 [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 Date2018-04-16
Device Publish Date2018-03-14

Devices Manufactured by Neusoft Medical Systems Co., Ltd.

06970167441616 - NeuViz 128 Multi-Slice CT Scanner System2023-10-31
06970167440046 - NeuViz 128 Multi-slice CT Scanner System2018-10-29
06970167440053 - NeuSight PET/CT Scanner System2018-06-15
06970167440077 - NeuViz Prime Multi-Slice CT Scanner System2018-04-16
06970167440077 - NeuViz Prime Multi-Slice CT Scanner System2018-04-16
06970167440084 - NeuViz 16 Essence Multi-Slice CT Scanner System2018-04-16
06970167440008 - NeuViz 64 Multi-slice CT Scanner System2018-03-29
06970167440015 - NeuViz 64 Multi-slice CT Scanner System2018-03-29
06970167440022 - NeuViz 64 Multi-slice CT Scanner System2018-03-29

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