# K020658: Viatronix V3D Colon

- Pathway: 510(k) (Abbreviated)
- Applicant: Viatronix, Inc.
- Decided: Mar 7, 2002 after 6 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.
4 later devices descend from it; 1 cites it directly.
0 of 10 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
- K023943: CT Colonography (2003), 3 descendants of its own
- K041270: CT Colonography II (2004), 2 descendants of its own
- K090220: Colon View, Model CSCV-001A (2009), 0 descendants of its own
- K061372: Centricity AW Suite Option (2006), 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 screening a colon to detect polyps, masses, cancers 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 screening a colon. 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/K020658
Methodology: https://510kreport.com/methodology