Radiology AI Directory

FDA-cleared profile

Methinks CTA Stroke

Methinks Software S.L.

Authorized purpose: 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 and sends PACS and/or specialist notifications in parallel to standard care; previews are informational and not diagnostic.

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.

Product overview

Start with the essentials

Authorized purpose: 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 and sends PACS and/or specialist notifications in parallel to standard care; previews are informational and not diagnostic.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: 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 and sends PACS and/or specialist notifications in parallel to standard care; previews are informational and not diagnostic.

Evidence takeaway

Evidence from the reviewed source record: Retrospective blinded multicenter multinational validation used 336 CTA cases, including 110 LVO-positive and 226 LVO-negative cases from institutions distinct from training data.

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 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 and sends PACS and/or specialist notifications in parallel to standard care; previews are informational and not diagnostic.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Intended users
Trained physicians, including emergency physicians, neurologists, radiologists, neuroradiologists, neurovascular interventionists, and other trained stroke professionals
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Care setting and population
Adult acute-stroke hospital workflow; patients above 21 years with suspected acute stroke
  • 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
Brain CT angiography in DICOM format from adults above 21 years with suspected acute stroke; the algorithm evaluates the terminal ICA, MCA-M1, and MCA-M2 territories.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Output and human action
A suspected-LVO notification sent to PACS and/or notification clients for the neurovascular specialist; images may be previewed in an informational viewer, while notified clinicians must review non-compressed diagnostic images and the full patient context.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Limitations
Preview is informational and not diagnostic; the device is not a replacement for full clinical evaluation, standard care, or physician interpretation.
  • 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
K251590
  • 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
2025-08-20
  • 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 submission describes DICOM ingestion, PACS delivery, and notification clients for parallel specialist notification; site-specific interfaces and routing rules require confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

The reviewed exact-submission material establishes PACS/notification workflow but not a current hosting model or regional data flow.

Security and privacy
The FDA submission describes a risk-based cybersecurity process including threat modeling, vulnerability assessment, third-party penetration testing, SBOM, authentication/authorization, logging, cryptography, monitoring, and recovery controls; current attestation, scope, and expiration were not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

This records controls described in the submission, not 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.

CTA-to-PACS notification

The exact submission describes DICOM CTA ingestion, LVO analysis in the terminal ICA/MCA-M1/MCA-M2, and notifications to PACS and/or specialist clients in parallel to standard care.

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 K251590 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 used 336 CTA cases, including 110 LVO-positive and 226 LVO-negative cases from institutions distinct from training data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Reported sensitivity
98.2% (95% CI 93.6%-99.8%) for LVO detection in 336 cases.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Reported specificity
91.6% (95% CI 87.2%-94.9%) for LVO detection in 336 cases.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

Sensitivity

98.2 percent

  • EndpointLVO detection
  • Population336 CTA cases; 110 LVO-positive and 226 LVO-negative
  • Tested versionMethinks CTA Stroke submitted in K251590; build not stated
Source

Specificity

91.6 percent

  • EndpointLVO detection
  • Population336 CTA cases; 110 LVO-positive and 226 LVO-negative
  • Tested versionMethinks CTA Stroke submitted in K251590; build not stated
Source

Mean time to notification

3.3 minutes

  • EndpointDICOM receipt through analysis and PACS/client notification
  • PopulationCTA cases in the FDA workflow timing evaluation
  • Tested versionMethinks CTA Stroke submitted in K251590; build not stated
Source

Methinks CTA Stroke multicenter LVO validation

  • DesignRetrospective blinded multicenter multinational standalone performance study
  • Population336 CTA cases, including 110 LVO-positive and 226 LVO-negative cases from institutions distinct from training data
  • Scopeexact submission
  • Tested versionMethinks CTA Stroke submitted in K251590; build not stated
  • Samplen=336
  • IndependenceIndependence not established

K251590

The FDA describes cases from institutions distinct from training data; two U.S.-board-certified neuroradiologists interpreted cases with third-reader adjudication. Independence of investigators or sponsorship was not established.

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) K251590: Methinks CTA Stroke

    U.S. Food and Drug Administration - Published 2025-08-20 - Accessed 2026-09-06

    Scope: identity, purpose, clinicalUse, modality, anatomy, input, output, limitations, integration, 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 CTA Stroke model card (K251590)

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

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

    Methinks - Accessed 2026-09-07

    Scope: productFamilyWorkflow, implementationCapabilities

Research history

  1. K251590 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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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...

Modality
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Anatomy
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Decision
2025-06-16
Stroke and ICH triageAcute triage and notification