# K261916: NeuroQuant PET

- Pathway: 510(k) (Traditional)
- Applicant: Cortechs Labs, Inc.
- Decided: Aug 12, 2026 after 64 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010641 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231576: cNeuro cPET, Combinostics OY (2023) Summary page 5.

## Indications for use
NeuroQuant PET 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. The software generates DICOM PET-MRI and PET-CT fusion images that aid in discerning anatomical patterns of PET tracer uptake. When MRI data is available, the software provides volumetry measurements. NeuroQuant PET is intended to support the clinical interpretation of PET imaging performed for the assessment of cognitive impairment and other neurological conditions.

Source page: https://510kreport.com/device/K261916
Methodology: https://510kreport.com/methodology