# K040126: Viatronix V3D Colon, Revision 1.3

- Pathway: 510(k) (Traditional)
- Applicant: Viatronix, Inc.
- Decided: Apr 19, 2004 after 90 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). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 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.
- K973010: Realtime 3D Diagnostic Workstation, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K012072: Voxar VC, Model 1.0, Voxar Limited (2001) Summary page 2.
- K002519: Vitrea 2, Version 2.1, Vital Images, Inc. (2000) Summary page 2.
- K002780: Viatronix Visualization System (VVS), Viatronix, Inc. (2000) Summary page 2.

## Most influential descendants
- K123566: Synapse 3D Colon Analysis (2013), 0 descendants of its own
- K111758: Cadens (TM) Colon (2012), 0 descendants of its own

## Indications for use
The Viatronix V3D Colon is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT and MR scans, for the purpose of patient screening for detection of colon cancers, polyps, masses, and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. It generates a centerline for guided interactive navigation and fly through of the entire colon, and also includes a reporting facility to enhance workflow for patient screening. It is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive print and distribute colon image studies utilizing PC hardware.

Source page: https://510kreport.com/device/K040126
Methodology: https://510kreport.com/methodology