FDA.reportPublic FDA data

V3D-Calcium Scoring

Primary DI
B209CAS2X00
Brand
V3D-Calcium Scoring
Company
VIATRONIX INCORPORATED
Model
2.0
Device description
V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent.
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
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B209CAS2X00PrimaryHIBCC0

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
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
B209XP2X00V3D-Explorer2.02016-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884521785977superDimensionCovidien LPJAK2026-05-29
10884521851184superDimensionCovidien LPJAK2026-05-29
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
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00884838126398Spectral CT Verida RTPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127555Upgrade Spectral CT VeridaPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127562Upgrade Spectral CT Verida RTPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127883Upgrades Spectral CT 7500 RT SW5.4Philips Medical Systems Nederland B.V.JAK2026-05-26
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITEDJAK2026-03-30
08719326703824LungQ®Thirona B.V.JAK2026-02-12
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
00884838119253Spectral CT System UpgradesPhilips Medical Systems Nederland B.V.JAK2025-05-25
10884521852198superDimensionCovidien LPJAK2025-05-18