# K012313: CT Colonography/NAVIGATOR2

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Aug 7, 2001 after 15 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954355 (1995). 1 ancestor in all.
580 later devices descend from it; 3 cite it directly.
1 of 582 devices in its family (counting itself) has 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.

## Most influential descendants
- K041521: Volume Viewer Plus (2004), 469 descendants of its own
- K030982: Syngo Colonography Software Package (2003), 227 descendants of its own
- K061696: Iqqa-Liver Software (2006), 217 descendants of its own
- K033102: Medic Colon Model, Release 1 (2003), 210 descendants of its own
- K042674: Colon Car 1.2 (2004), 209 descendants of its own

## Recalls of this device
- May 24, 2012 · Class II · Z-1960-2012: GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion 

## Indications for use
CT Colonography/Navigator2 is an image analysis software package that contains CT Colonogarphy and Navigator2. CT Colonography allows the user to study the inside, wall and outside of the colon. It provides the user with an ability to view datasets from both, prone and supine positions, facilitating detection of colonic lesions. In comparison to colonoscopy, this tool has an advantage of non-invasive depth penetration due to its 3D presentation capability. Navigator2 provides endoluminal views of anatomical structures. Navigator2 is designed to enhance and modify current image quality, tools, speed and user interface of Navigator for improved productivity. Navigator2 provides a visualization tool to investigate structures (such as polyps, tumors, stones, calcification etc.) within anatomy, airways and organs. Thus, its viewing capability of the inner and outer surfaces of organs as well as within their walls provides additional supplemental information, complementing endoscopy/colonoscopy, to support interpretation and treatment planning. Navigation2 is applicable to X-ray as well as CT/MR.

Source page: https://510kreport.com/device/K012313
Methodology: https://510kreport.com/methodology