# K083293: Viatronix V3D-Cardiac, Revision 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Viatronix, Inc.
- Decided: Dec 5, 2008 after 25 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000315 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041267: Cardiq Analysis Iii, General Electric Medical Systems (2004) Summary page 1.
- K013422: Cardiq Function, GE Medical Systems (2001) Summary page 1.

## Indications for use
The Viatronix V3D-Cardiac is intended to be used for the display and 2D/3D visualization of medical image data derived from CT of the human heart. The goal of this non-invasive, image analysis software package is to assist physician in diagnosing of cardiovascular disease to include, coronary artery disease, functional problem of left ventricle, myocardium anomaly, other heart diseases, and follow-up for stent/graft placement, bypasses and plaque imaging. The image post-processing tools are applied real time on-line by the physician's interactive demand. There is no image processing stage required prior to the start of the using of the V3D-Cardiac. The Viatronix V3D-Cardiac provides a set of fully or semi-automated tools, including, rib cage removal, initial coronary vessel tree segmentation, selected vessel segmentation, vessel cross-sectional size measurements, and left ventricle volume functional parameter computation. The V3D-Cardiac will also provide automated setting and display of conventional cardiac imaging planes based on a single user input: selection of the center of the aorta valve. The automatic 2D/3D view correlation is available for vessel analysis views. User can virtually fly thru the vessel lumen in the endoluminal 3D view. Manual tools for adjusting location of center of mitral valve for left ventricle region segmentation are provided. The V3D-Cardiac is intended for use by radiologist, clinicians and referring physicians to acquire, process, render, measure, evaluate, archive, print and distribute DICOM 3.0 compliant coronary artery, left ventricle and other heart anatomy images, utilizing PC hardware.

Source page: https://510kreport.com/device/K083293
Methodology: https://510kreport.com/methodology