510(k) · Cleared

Cleared

GyriCalc (Version 1.0.0)

K250686510(k) TraditionalCleared Jul 22, 2025138-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Neurospectrum Insights Corp. · LLZ System, Image Processing, Radiological

Cleared on Jul 22, 2025 as substantially equivalent to K170981 (Cortechs Labs, Inc., 2017) after a 138-day review. Its family tree reaches back 2 generations to 2006.

Decided: Jul 22, 2025
Review: 138 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K061855 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
1 generation backK170981 NeuroQuantCortechs Labs, Inc. · 2017
This deviceK250686 GyriCalc (Version 1.0.0)Neurospectrum Insights Corp. · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K061855	Neuroquant	Cortechs Labs, Inc.	2006	—
−1	K170981	NeuroQuant	Cortechs Labs, Inc.	2017	—
0 (this device)	K250686	GyriCalc (Version 1.0.0)	Neurospectrum Insights Corp.	2025	—

FIG. 1 — Lineage of K250686, 2006–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K170981	NeuroQuant Summary page 5 …s Class II Panel Radiology 3. PREDICATE DEVICE INFORMATION Predicate Device Name NeuroQuant Predicate Device K Number K170981 Product Code LLZ Regulation Number 892.2050 510(k) Summary…	Cortechs Labs, Inc.	2017	—
†	K220437	Neurophet AQUA	Neurophet., Inc.	2023	—

Also cleared against K170981: 13 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
None of the 2 ancestors has a recall.
13 other devices also cite its predicate K170981.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K250686 · printed Nov 6, 2026

Cite this page

510(k) Report. “K250686: GyriCalc (Version 1.0.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250686

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026