# K023943: CT Colonography

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: May 6, 2003 after 161 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: 2 generations back to K954355 (1995). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012313: CT Colonography/NAVIGATOR2, Ge Medical Systems, Inc. (2001)
- K020658: Viatronix V3D Colon, Viatronix, Inc. (2002) Summary page 2.

## Most influential descendants
- 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
CT Colonography is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of supine & prone data sets, and an object oriented endoluminal display. In comparison to colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print and distribute colon image studies.

Source page: https://510kreport.com/device/K023943
Methodology: https://510kreport.com/methodology