V3D-Calcium Scoring

FDA UDI

Class II (US FDA UDI)

by Viatronix Incorporated

Identity

Trade Name: V3D-Calcium Scoring FDA UDI
Generic Name: Radiological PACS software FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 2.0 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: B209CAS2X00 FDA UDI
FDA Product Code: JAK FDA UDI
GMDN Term: Radiological PACS software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

Yes

FDA UDI

Category: Radiological PACS software

V3D-Calcium Scoring by Viatronix Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

AVIEW — CORELINE SOFT CO., LTD. · Class II
ThinkingNet — THINKING SYSTEMS CORP. · Class II
IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
EAGLESOFT — PATTERSON TECHNOLOGY CENTER · Class II
QuantX — Qlarity Imaging · Class II
interWORKS — Avreo, Inc. · Class I
NovaPACS — Novarad Corporation · Class II
OrthoNext™ Platform System Software — Orthofix, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Viatronix Incorporated

Sources (1)

FDA UDI babd4924-e914-4ac0-8db5-7455fcea168b 34 fields · synced May 29, 2026