V3D-Calcium Scoring

GUDID B209CAS2X10

V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICO

VIATRONIX INCORPORATED

Radiology picture archiving and communication system application software
Primary Device IDB209CAS2X10
NIH Device Record Keybeb3330e-921d-4aad-a113-6b50eaa0dd7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameV3D-Calcium Scoring
Version Model Number2.1
Company DUNS017608345
Company NameVIATRONIX INCORPORATED
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com
Phone(631) 771-1801
Emailcsdsupport@viatronix.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB209CAS2X10 [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 Number3
Public Version Date2018-09-24
Device Publish Date2016-06-17

On-Brand Devices [V3D-Calcium Scoring]

B209CAS2X10V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery
B209CAS2X00V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery

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