# K141074: Cortex ID Suite

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Sep 18, 2014 after 146 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: 6 generations back to K010641 (2001). 12 ancestors in all.
2 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)
- K062393: GE Vantage Pet Neuro Software, GE Healthcare (2006) Summary page 5.

## Most influential descendants
- K231576: cNeuro cPET (2023), 1 descendant of its own
- K261916: NeuroQuant PET (2026), 0 descendants of its own

## Indications for use
CortexID software has been developed to aid physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans. The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain. The package allows the user to gencrate information regarding relative changes in PET-FDG glucose metabolism. CortexID Suite additionally allows the user to generate information in PET brain amyloid load between a subject’s images and a normal database, which may be the result of brain neurodegeneration. PET co-registration and fusion display capabilities with CT and MR allow PET findings to be related to brain anatomy and offers visualization of structural abnormalities, which may result from brain injury, trauma, disorder, disease or dysfunction, such as subdural hematoma, tumor, stroke, or cerebrovascular disease, etc. CortexID Suite may aid physicians in the image interpretation process of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline, and is an adjunct to other diagnostic evaluations.

Source page: https://510kreport.com/device/K141074
Methodology: https://510kreport.com/methodology