# K220437: Neurophet AQUA

- Pathway: 510(k) (Traditional)
- Applicant: Neurophet., Inc.
- Decided: May 10, 2023 after 448 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: 2 generations back to K061855 (2006). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 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 5.

## Most influential descendants
- K242215: Neurophet AQUA (V3.1) (2024), 2 descendants of its own
- K261273: Neurophet AQUA (2026), 0 descendants of its own
- K251483: SwiftSight-Brain (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K220437
Methodology: https://510kreport.com/methodology