# K231576: cNeuro cPET

- Pathway: 510(k) (Traditional)
- Applicant: Combinostics OY
- Decided: Sep 14, 2023 after 106 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: 7 generations back to K010641 (2001). 13 ancestors in all.
1 later device descends 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)
- K141074: Cortex ID Suite, Ge Medical Systems, LLC (2014) Summary page 4.

## Most influential descendants
- K261916: NeuroQuant PET (2026), 0 descendants of its own

## Indications for use
cNeuro cPET aids 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 and voxel-based maps of the brain. cNeuro cPET allows the user to generate information regarding relative changes in PET-FDG glucose metabolism. cNeuro cPET additionally allows the user to generate information regarding relative changes in PET brain amyloid load between a subject’s images and a hormal database, which may be the result of brain neurodegeneration. PET co-registration and fusion display capabilities with MRI allow PET findings to be related to brain anatomy. cNeuro cPET aids physicians in the image interpretation of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline.

Source page: https://510kreport.com/device/K231576
Methodology: https://510kreport.com/methodology