FDA.reportPublic FDA data

V3D-Explorer

Primary DI
B209XP2X00
Brand
V3D-Explorer
Company
VIATRONIX INCORPORATED
Model
2.0
Device description
V3D-Explorer is a software application used with advanced PC hardware for the display and 3D visualization of DICOM 3.0 compliant medical images derived from CT, MRI, PET and SPECT scans. The linear, angular and volume measurement features provided in the software for the evaluation and quantification of organ, hard and soft tissues as well as internal organ structures for lesion, mass and other anomalies. It also supports interactive segmentation of any organ.
Published
2016-06-02
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
B209XP2X00PrimaryHIBCC0

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
B209VC4X1X1X150V3D-Colon4.1.1.152016-06-17
B209VC4X1X2X110V3D-Colon4.1.2.112016-06-17
B209VC4X1X2X320V3D-Colon4.1.2.322016-06-17
B209VC4X1X2X330V3D-Colon4.1.2.332016-06-17

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