# K250686: GyriCalc (Version 1.0.0)

- Pathway: 510(k) (Traditional)
- Applicant: Neurospectrum Insights Corp.
- Decided: Jul 22, 2025 after 138 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
GyriCalc is intended for automatic labeling, visualization, and quantification including volume, surface area and gyrification analysis (i.e., gyrification index) of segmentable brain structures from a set of MR images. GyriCalc is intended to be used by qualified personnel and interpreted by a qualified clinician. GyriCalc is not intended to be used for visualization or quantification of neurologic lesions. GyriCalc is intended for children between 24 to 36 months of age.

Source page: https://510kreport.com/device/K250686
Methodology: https://510kreport.com/methodology