Radiology AI Directory

FDA-cleared profile

GyriCalc (Version 1.0.0)

NeuroSpectrum Insights Corp.

Adjunctive quantitative brain-mapping report for qualified clinical interpretation of children 24-36 months, providing regional volume, surface-area and local-gyrification measures from 3D T1 MRI.

Quantification and segmentationNeuro MRI
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Adjunctive quantitative brain-mapping report for qualified clinical interpretation of children 24-36 months, providing regional volume, surface-area and local-gyrification measures from 3D T1 MRI.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Intended users
Qualified healthcare professionals and clinicians interpreting pediatric brain MRI.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Care setting and population
Pediatric neuroimaging services for children 24-36 months.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Workflow role
Automated brain-mapping and quantitative reporting aid; it is not a primary image-review or diagnostic system.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Required input
3D T1-weighted DICOM brain MRI acquired at 1.5T or 3T; the ideal isotropic resolution and slice thickness are 1 mm.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Output and human action
Automatic labels, visualizations and quantitative measures for brain-structure volume, surface area and local gyrification index, delivered as a PDF report.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Limitations
GyriCalc is not intended for primary image review, lesion visualization or lesion quantification, emergency use, diagnosis or aid in diagnosis, and the cleared age range is 24-36 months. Results require qualified clinical interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K250686
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-07-22
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
The FDA submission describes DICOM MRI input and PDF report output; public buyer material describes a processing-center workflow, while local DICOM routing and report delivery require confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Deployment and data flow
The reviewed public filing describes completed MRI studies being sent to a NeuroSpectrum Insights processing center and a PDF report being delivered to the ordering clinician.
  • Public source
  • Product family
  • Checked 2026-09-06

The filing describes the company's planned commercialization workflow and does not establish current availability or a site-specific service commitment.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

The reviewed product page and filing do not establish exact-release security controls, retention or assurance documentation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

PDF brain-mapping report

The cleared product produces a PDF report with regional volume, surface-area and local-gyrification measures.

exact submission · checked 2026-09-07
Source

Processing-center report workflow

The public commercialization filing describes an ordering clinician sending a completed MRI to a NeuroSpectrum Insights processing center and receiving a PDF report.

product family · checked 2026-09-06

The filing describes a planned workflow and does not establish current availability, turnaround, contract terms or security controls.

Source

Artifact correction and standardized reporting

The official GyriCalc page describes correction for motion, intensity inhomogeneity and other artifacts, segmentation of cortical regions, and standardized qualitative/quantitative reporting.

exact product version · checked 2026-09-06
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
The FDA-described independent test used 82 T1 MRI studies from 82 children aged 24-36 months, with six experts providing reference segmentations. Average Dice was 0.95. Reported volume MAE ranged from 0.45% to 12.1%, surface-area MAE from 0.33% to 12.6%, and gyrification error from 0.04% to 0.89%; the source identifies several regions exceeding 10% volume or surface-area error.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-07

The cleared endpoints are segmentation and quantitative agreement measures, not disease-detection sensitivity.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-07

The cleared endpoints are segmentation and quantitative agreement measures, not disease-detection specificity.

Segmentation Dice

0.95 Dice coefficient, average

  • EndpointSegmentation overlap
  • Population82 independent 3D T1 MRI studies from children aged 24-36 months
  • Tested versionGyriCalc 1.0.0 configuration submitted in K250686
Source

Volume MAE lower bound

0.45 percent absolute error, lower endpoint of reported range

  • EndpointRegional volume mean absolute error
  • Population82 independent 3D T1 MRI studies from children aged 24-36 months
  • Tested versionGyriCalc 1.0.0 configuration submitted in K250686
Source

Volume MAE upper bound

12.1 percent absolute error, upper endpoint of reported range

  • EndpointRegional volume mean absolute error
  • Population82 independent 3D T1 MRI studies from children aged 24-36 months
  • Tested versionGyriCalc 1.0.0 configuration submitted in K250686
Source

Surface-area MAE lower bound

0.33 percent absolute error, lower endpoint of reported range

  • EndpointRegional surface-area mean absolute error
  • Population82 independent 3D T1 MRI studies from children aged 24-36 months
  • Tested versionGyriCalc 1.0.0 configuration submitted in K250686
Source

Surface-area MAE upper bound

12.6 percent absolute error, upper endpoint of reported range

  • EndpointRegional surface-area mean absolute error
  • Population82 independent 3D T1 MRI studies from children aged 24-36 months
  • Tested versionGyriCalc 1.0.0 configuration submitted in K250686
Source

Gyrification error lower bound

0.04 percent error, lower endpoint of reported range

  • EndpointLocal gyrification index error
  • Population82 independent 3D T1 MRI studies from children aged 24-36 months
  • Tested versionGyriCalc 1.0.0 configuration submitted in K250686
Source

Gyrification error upper bound

0.89 percent error, upper endpoint of reported range

  • EndpointLocal gyrification index error
  • Population82 independent 3D T1 MRI studies from children aged 24-36 months
  • Tested versionGyriCalc 1.0.0 configuration submitted in K250686
Source

GyriCalc 1.0.0 pediatric brain-mapping validation

  • DesignIndependent segmentation and quantitative agreement study with six experts in two groups of three and STAPLE reference generation
  • Population82 independent normal-appearing 3D T1 MRI studies from children aged 24-36 months: 54 U.S. and 28 Brazil; 67 at 1.5T and 15 at 3T; Philips 25, GE 56 and Siemens 1
  • Scopeexact submission
  • Tested versionGyriCalc 1.0.0 configuration submitted in K250686
  • Samplen=82
  • IndependenceSponsor or vendor study

K250686

FDA reports average Dice 0.95, volume MAE 0.45%-12.1%, surface-area MAE 0.33%-12.6% and gyrification error 0.04%-0.89%. Several regional volume/surface values exceeded 10%; no averaging is added here.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
A public SEC filing describes a predetermined per-patient list price for GyriCalc report generation and delivery, but does not disclose the dollar amount, terms or current availability.
  • Public source
  • Exact product version
  • Checked 2026-09-06

This is a commercialization-plan statement, not a current quote or reimbursement amount.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-07

Payer policy research was not part of this worker's scope.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-07

The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-07Last searched
22Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored candidate metadata was screened; no PubMed or trial IDs were returned for this submission. This is not a full-paper review. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, sec filing, stored candidate metadata, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA 510(k) K250686: GyriCalc

    U.S. Food and Drug Administration - Accessed 2026-09-07

    Scope: identity, purpose, clinicalUse, modality, anatomy, workflowRole, intendedUsers, careSetting, input, output, limitations, integration, deployment, reportedSensitivity, reportedSpecificity, evidenceMetrics, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. GyriCalc (Version 1.0.0) model card (K250686)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. GyriCalc - Innovative Brain Mapping and Analysis Technology

    NeuroSpectrum Insights - Accessed 2026-09-06

    Scope: clinicalUse, output, limitations, implementationCapabilities

  8. NeuroSpectrum Insights commercialization filing (GyriCalc)

    U.S. Securities and Exchange Commission - Accessed 2026-09-06

    Scope: economics, implementationCapabilities

Research history

  1. K250686 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

Alternatives

Related tools to compare

FDA-cleared K261405

ANDI 2.2

Imeka Solutions, Inc.

ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained...

Modality
MRI
Anatomy
Brain
Decision
2026-05-28
Quantification and segmentationNeuro MRI
FDA-cleared K260032

Morph

BeauBrain Healthcare, Inc.

Morph automatically labels, visualizes, and volumetrically quantifies segmentable brain structures from MR images and may compare measurements with reference percentile data; it...

Modality
MRI
Anatomy
Brain
Decision
2026-05-13
Quantification and segmentationNeuro MRI
FDA-cleared K253057

AI-Rad Companion Brain MR

Siemens Healthcare GmbH

Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.

Modality
MRI
Anatomy
Brain
Decision
2026-01-22
Quantification and segmentationNeuro MRI
FDA-cleared K252298

ANDI 2.0

Imeka Solutions, Inc.

Adjunctive quantitative brain MRI analysis that compares patient measures with normative and longitudinal references; a physician reviews all results and makes the clinical...

Modality
MRI
Anatomy
Brain
Decision
2025-10-22
Quantification and segmentationNeuro MRI