# K062393: GE Vantage Pet Neuro Software

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 1, 2006 after 16 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010641 (2001). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041022: Neuroq - Pet DP, Syntermed, Inc. (2004) Summary page 1.
- K042863: Scenium, Siemens Molecular Imaging, Ltd. (2004) Summary page 1.

## Most influential descendants
- K141074: Cortex ID Suite (2014), 2 descendants of its own
- K231576: cNeuro cPET (2023), 1 descendant of its own
- K261916: NeuroQuant PET (2026), 0 descendants of its own

## Indications for use
The Vantage software has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET and PET-CT brain scans. The software is deployed via Advantage Windows Workstation and PET-CT scanner console and is organized as a series of workf'lows steps, which are specific to use with particular drug and disease combination. The software aids in the assessment of human brain scans enabling automated analysis through quantification of the comparison of local peak activity values at standardized anatomical locations with the corresponding reference normal peak activity in age stratified control subjects. The resulting quantification is presented to the user through 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG metabolic activity between a subjects images and age stratified controls, which may be resulting from brain function alterations by neurodegenerative processes. CT fusion to PET offers visualization of structural abnormalities, which may result from brain injury, trauma, disorder, disease or dysfunction, such as subdural hematorna, tumor, stroke (or cerebrovascutar disease) etc. Such tools may aid the physician in the rule out process.

Source page: https://510kreport.com/device/K062393
Methodology: https://510kreport.com/methodology