CT SCANNER

GUDID 04987670102691

CANON MEDICAL SYSTEMS CORPORATION

Full-body CT system
Primary Device ID04987670102691
NIH Device Record Key7b058ce8-afb6-45f0-8343-cd49e12eb82f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT SCANNER
Version Model NumberTSX-304A
Company DUNS690575113
Company NameCANON MEDICAL SYSTEMS CORPORATION
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-8004211968
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS104987670102691 [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 Number2
Public Version Date2018-07-06
Device Publish Date2018-04-09

On-Brand Devices [CT SCANNER]

04987670102691TSX-304A
04987670103797TSX-306A
04987670104671TSX-307A

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