V3D-Calcium Scoring

Basic Information

• Brand Name: V3D-Calcium Scoring
• Primary DI: B209CAS2X10
• Version / Model: 2.1
• Company Name: VIATRONIX INCORPORATED
• Labeler DUNS: 017608345
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-17
• Public Version: 5
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: beb3330e-921d-4aad-a113-6b50eaa0dd7e

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41670	Radiological PACS software	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B209CAS2X10	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]