# K241098: NeuroQuant

- Pathway: 510(k) (Traditional)
- Applicant: Cortechs Labs, Inc.
- Decided: Aug 22, 2024 after 122 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 2 generations back to K061855 (2006). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170981: NeuroQuant, Cortechs Labs, Inc. (2017) Summary page 4.

## Most influential descendants
- K252496: Neurophet AQUA AD Plus (2026), 1 descendant of its own
- K252563: Neurophet SCALE PET (2026), 0 descendants of its own

## Indications for use
NeuroQuant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric measurements may be compared to reference percentile data.

Source page: https://510kreport.com/device/K241098
Methodology: https://510kreport.com/methodology