Identity
- Trade Name
- V3D-Cardiac FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- V3D-Cardiac is a software application used with advanced PC hardware for evaluating DICOM 3.0 compliant CT images of the human heart. It is designed to aid the physician in analyzing the heart anatomy and detecting anomalies based on contrast enhanced CT images. It provides both coronary artery tracking and left ventricle volume analyzing tools for single or multi-phase CT scan. FDA UDI
- Model / Reference
- 1.1 FDA UDI
- Description
- V3D-Cardiac is a software application used with advanced PC hardware for evaluating DICOM 3.0 compliant CT images of the human heart. It is designed to aid the physician in analyzing the heart anatomy and detecting anomalies based on contrast enhanced CT images. It provides both coronary artery tracking and left ventricle volume analyzing tools for single or multi-phase CT scan. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B209CAR1X10 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological PACS software
V3D-Cardiac by Viatronix Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological PACS software.
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- 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 c974fbbd-f029-45ff-a683-3ff903457ba6 34 fields · synced May 30, 2026