# K033361: Viatronix V3D Vascular, Revision 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Viatronix, Inc.
- Decided: Nov 5, 2003 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K926258 (1993). 4 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993792: Smart Vessel Analysis (Smart VA) Option, Ge Medical Systems, Inc. (1999) Summary page 1.
- K002519: Vitrea 2, Version 2.1, Vital Images, Inc. (2000)

## Most influential descendants
- K073156: Qplaque MR (2008), 21 descendants of its own
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own
- K171222: Vitrea Software Toshiba Package; VSTP-001A (2017), 12 descendants of its own
- K173088: Vitrea Software Toshiba Package VSTP-001A (2018), 11 descendants of its own
- K183013: Vitrea Software Package, VSTP-001A (2018), 9 descendants of its own

## Indications for use
The Viatronix V3D Vascular is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MFU scans or 3D X-Ray angiography of the selected human vessels, e.g., the coronary arteries, the carotid arteries, the peripheral arteries, the aorta, arteries of the brain, and any opacified veins. The goal of this device is to automate routine inspection of human vessels to detect stenosis, plaque, bulge, aneurismal sac and dissection in the vessel. It also supports the interactive segmentation of any vessel by hiding certain parts of the data set from display for critical evaluation of selected part(s) of vessel. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, measure, evaluate, archive, print and distribute DICOM 3 .O compliant vessel image studies, utilizing PC hardware.

Source page: https://510kreport.com/device/K033361
Methodology: https://510kreport.com/methodology