# K022789: Viatronix V3D Explorer

- Pathway: 510(k) (Traditional)
- Applicant: Viatronix, Inc.
- Decided: Sep 6, 2002 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: 1 generation back to K954355 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954355: Advantage Windows 3D with Navigator Option, General Electric Co. (1995) Summary page 1.
- K002519: Vitrea 2, Version 2.1, Vital Images, Inc. (2000)
- K002780: Viatronix Visualization System (VVS), Viatronix, Inc. (2000) Summary page 1.

## Indications for use
The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET and SPECT scans of the human body including any organ. The volume, linear and angular measurement functions are intended for the evaluation and quantification of tumor or selected organ volume/linear measurements, angular location/ displacement, study/ analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp, lesion, mass, implants, fracture, aneurysms, stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant specified organ image studies, utilizing PC hardware.

Source page: https://510kreport.com/device/K022789
Methodology: https://510kreport.com/methodology