FDA.reportPublic FDA data

V3D-Colon

Primary DI
B209VC4X1X1X150
Brand
V3D-Colon
Company
VIATRONIX INCORPORATED
Model
4.1.1.15
Device description
V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon.
Published
2016-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B209VC4X1X1X150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system application softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(631) 771-1801csdsupport@viatronix.com

Regulatory Flags#

DUNS number
017608345
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B209CAR1X10V3D-Cardiac1.12016-06-17
B209CAS2X00V3D-Calcium Scoring2.02016-06-17
B209CAS2X10V3D-Calcium Scoring2.12016-06-17
B209VA2X00V3D-Vascular2.02016-06-02
B209VC3X3X3X10V3D-Colon3.3.3.12016-06-17
B209VC4X0X0X360V3D-Colon4.0.0.362016-06-17
B209VC4X0X0X44F0V3D-Colon4.0.0.442016-06-17
B209VC4X0X3X13F0V3D-Colon4.0.3.132016-06-17
B209VC4X0X3X40V3D-Colon4.0.3.42016-06-17
B209VC4X1X2X110V3D-Colon4.1.2.112016-06-17
B209VC4X1X2X320V3D-Colon4.1.2.322016-06-17
B209VC4X1X2X330V3D-Colon4.1.2.332016-06-17
B209XP2X00V3D-Explorer2.02016-06-02

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Primary DI, Brand, Company table
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