Radiology AI Directory

FDA-cleared profile

i2Contour

MRIMath LLC

Semi-automatic segmentation, labeling, and volumetric quantification of known WHO grade 4 glioblastoma in adults aged 18 years or older using T1 post-contrast or FLAIR MRI.

Quantification and segmentation
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
Semi-automatic segmentation, labeling, and volumetric quantification of known WHO grade 4 glioblastoma in adults aged 18 years or older using T1 post-contrast or FLAIR MRI.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Trained medical professionals, including board-certified neuroradiologists; professional review, manual completion, and approval are required.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Adult neuro-oncology and neuroimaging workflow for patients aged 18 years or older with pathologically proven grade 4 glioblastoma.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
AI-assisted contouring and volumetric measurement aid; the AI supplies an initial contour for trained-professional review and manual revision, with prior-scan comparison and reporting, and is not a detection or diagnosis tool.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM MRI in 2D or 3D using either T1 post-contrast (T1c) or FLAIR sequences from male or female patients aged 18 years or older with pathologically proven WHO grade 4 glioblastoma.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Segmentation contours and volumes for tumor, edema, and necrosis subcomponents in FLAIR and enhancing and necrosis subcomponents in T1c, comparison with prior scans when available, and a PDF report.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The device is not for primary diagnosis, tumor detection, or use as the sole diagnostic metric, and is not intended for brain tumor types other than grade 4 glioblastoma. A trained professional must review and complete the contours; the packet does not establish use for other sequences or populations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K233822
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain and glioblastoma
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-08-08
  • 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
Web-based software with DICOM MRI input and PDF report output; exact hosting, PACS/RIS/EHR interfaces, versions, and local compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-cloud
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for i2Contour; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
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
FDA performance testing compared AI contours with manual contours by three U.S. board-certified neuroradiologists on 46 pre- and post-operative MRIs from 19 U.S. centers. T1c mean overall DSC was 0.95 (95% CI 93%-96%); true-positive T1c mean DSC was 83%, with sensitivity 92.7% and specificity 97.2%. FLAIR mean overall DSC was 92% (95% CI 90%-94%); true-positive FLAIR mean DSC was 80%, with median sensitivity 93.4% and specificity 98.6%. The proportions of DSC measurements exceeding the 0.88 threshold were 85% for FLAIR (95% CI 72%-92%) and 93% for T1c (95% CI 82%-98%), both p<0.001.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
T1c: 92.7%; FLAIR: median 93.4%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

T1c and FLAIR endpoints are retained separately; Dice values and threshold-exceedance proportions are not sensitivity or specificity.

Reported specificity
T1c: 97.2%; FLAIR: median 98.6%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

T1c and FLAIR endpoints are retained separately; Dice values and threshold-exceedance proportions are not sensitivity or specificity.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

i2Contour regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K233822
  • Samplen=33
  • IndependenceIndependence not established

K233822

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K233822 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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
The exact-identifier FDA recall query returned no native recall record for K233822. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

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
2026-09-08Last searched
24Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, 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 K233822: i2Contour

    U.S. Food and Drug Administration - Published 2024-08-08 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. i2Contour model card (K233822)

    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. openFDA exact recall query for K233822

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K233822 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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