# K170981: NeuroQuant

- Pathway: 510(k) (Traditional)
- Applicant: Cortechs Labs, Inc.
- Decided: Sep 7, 2017 after 157 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: 1 generation back to K061855 (2006). 1 ancestor in all.
28 later devices descend from it; 14 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061855: Neuroquant, Cortechs Labs, Inc. (2006) Summary page 4.

## Most influential descendants
- K220437: Neurophet AQUA (2023), 3 descendants of its own
- K221738: NS-HGlio (2022), 3 descendants of its own
- K242215: Neurophet AQUA (V3.1) (2024), 2 descendants of its own
- K241098: NeuroQuant (2024), 2 descendants of its own
- K232231: QP-Brain® (2023), 2 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/K170981
Methodology: https://510kreport.com/methodology