Radiology AI Directory

FDA-cleared profile

Methinks NCCT Stroke

Methinks Software S.L.

Methinks NCCT Stroke analyzes adult non-contrast head CT to flag suspected intracranial hemorrhage and suspected large-vessel occlusion of the ICA, MCA-M1, or MCA-M2 for parallel workflow triage via PACS and/or notifications; previews are informational, not diagnostic, and a negative notification does not rule out LVO or replace CTA/standard care.

Stroke and ICH triageAcute triage and notification
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
Methinks NCCT Stroke analyzes adult non-contrast head CT to flag suspected intracranial hemorrhage and suspected large-vessel occlusion of the ICA, MCA-M1, or MCA-M2 for parallel workflow triage via PACS and/or notifications; previews are informational, not diagnostic, and a negative notification does not rule out LVO or replace CTA/standard care.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Intended users
Trained physicians and stroke clinicians responsible for acute head CT review and patient evaluation
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Care setting and population
Adult acute-stroke hospital workflow
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Workflow role
Triage and notification support
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Required input
Adult non-contrast head CT in DICOM format; the device evaluates suspected intracranial hemorrhage and ICA/MCA-M1/MCA-M2 LVO findings. CTA remains standard care for LVO evaluation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Output and human action
PACS and/or notification-client alerts for suspected intracranial hemorrhage or suspected LVO; a preview may be shown for information, while clinicians must review the original diagnostic images and full patient context.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Limitations
The preview is not diagnostic, a negative result does not rule out LVO, and the device does not replace CTA, standard care, or full clinical evaluation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

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
K250685
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-06-16
  • 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 NCCT ingestion, PACS delivery, and notification clients for parallel triage; local routing, interfaces, and escalation policy require confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Deployment and data flow
Cloud-based deployment is explicitly described in the exact-submission source; hosting region, data flow, retention, and current commercial configuration require vendor confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-06
Security and privacy
The FDA submission describes a risk-based cybersecurity process including SBOM, third-party penetration testing, authentication/authorization, logging, cryptography, monitoring, and recovery controls; current attestation and scope were not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

Submission-described controls are not treated as a current independent security certification.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

Current onboarding, competency, and support commitments were not established.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

Local acceptance testing, production monitoring, update control, and drift review were not established.

Cloud NCCT triage workflow

The exact submission describes cloud-based DICOM NCCT processing with PACS and notification-client alerts for ICH and LVO triage.

exact submission · checked 2026-09-06
Source

Methinks family coordination workflow

Methinks' official platform page describes NCCT/CTA stroke workflows with AI alerts, team coordination, video communication, image viewing, and Microsoft Teams integration; the current configuration of K250685 requires confirmation.

product family · checked 2026-09-07
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
Retrospective blinded multicenter multinational validation included separate ICH and LVO cohorts; the FDA packet reports 358 ICH cases and 335 LVO cases.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Reported sensitivity
ICH sensitivity 94.7% (95% CI 89.3%-97.8%); LVO sensitivity 76.4% (95% CI 67.3%-83.9%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Reported specificity
ICH specificity 99.5% (95% CI 97.5%-99.9%); LVO specificity 91.1% (95% CI 86.6%-94.5%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

ICH sensitivity

94.7 percent

  • EndpointIntracranial hemorrhage detection
  • Population358 NCCT cases; 132 positive and 226 negative
  • Tested versionMethinks NCCT Stroke submitted in K250685; build not stated
Source

ICH specificity

99.5 percent

  • EndpointIntracranial hemorrhage detection
  • Population358 NCCT cases; 132 positive and 226 negative
  • Tested versionMethinks NCCT Stroke submitted in K250685; build not stated
Source

LVO sensitivity

76.4 percent

  • EndpointLVO detection on NCCT
  • Population335 NCCT cases; 110 positive and 225 negative
  • Tested versionMethinks NCCT Stroke submitted in K250685; build not stated
Source

LVO specificity

91.1 percent

  • EndpointLVO detection on NCCT
  • Population335 NCCT cases; 110 positive and 225 negative
  • Tested versionMethinks NCCT Stroke submitted in K250685; build not stated
Source

Methinks NCCT Stroke multicenter ICH and LVO validation

  • DesignRetrospective blinded multicenter multinational standalone performance study
  • PopulationSeparate NCCT cohorts: 358 ICH cases and 335 LVO cases
  • Scopeexact submission
  • Tested versionMethinks NCCT Stroke submitted in K250685; build not stated
  • Samplen=693
  • IndependenceIndependence not established

K250685

The FDA reports separate evaluation cohorts and notification timing of about 1.4 minutes for each task; this does not establish independent investigators or sponsorship. Reader-study results are kept distinct from standalone cohort metrics.

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 2026-09-07

No public amount, range, currency, geography, or contract term was established.

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

No payer or CMS policy review was performed in this worker cohort.

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 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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.

Human reviewedStatus
2026-09-07Last searched
26Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

No stored PubMed or ClinicalTrials.gov candidate identifiers for this submission in the 2026-09-01 snapshot; exact-submission recall candidate review was also zero. This metadata screen 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, literature index, trial registry, fda device recall, 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) K250685: Methinks NCCT Stroke

    U.S. Food and Drug Administration - Published 2025-06-16 - Accessed 2026-09-06

    Scope: identity, purpose, clinicalUse, modality, anatomy, input, output, limitations, integration, deployment, evidenceSummary, evidenceMetrics, evidenceStudies, security

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Methinks NCCT Stroke model card (K250685)

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

    Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, deployment, 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. Methinks official stroke platform page

    Methinks - Accessed 2026-09-07

    Scope: productFamilyWorkflow, implementationCapabilities

Research history

  1. K250685 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

Alternatives

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FDA-cleared K251590

Methinks CTA Stroke

Methinks Software S.L.

Methinks CTA Stroke analyzes acute-setting brain CT angiography in adults over 21 with suspected stroke for suspected large-vessel occlusion in the terminal ICA, MCA-M1, or MCA-M2...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-08-20
Stroke and ICH triageAcute triage and notification