Radiology AI Directory

FDA-cleared profile

Brainomix 360 Triage LVO

Brainomix Limited

Notification-only, parallel triage of acute-setting brain CTA studies for suspected large-vessel occlusion (LVO), communicating cases to a neurovascular specialist for review; not diagnostic.

Acute 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
Notification-only, parallel triage of acute-setting brain CTA studies for suspected large-vessel occlusion (LVO), communicating cases to a neurovascular specialist for review; not diagnostic.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Hospital networks and trained clinicians, with notification to neurovascular specialists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Clinical/hospital environment and hospital-network acute-care workflow; the comparison table identifies a clinical/hospital environment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Notification-only parallel worklist prioritization for suspected LVO, without image-region marking or removal/deprioritization of cases.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DICOM-compliant acute-setting brain CTA images evaluating terminal intracranial ICA and proximal MCA-M1 vessels; no patient-age restriction is stated in the FDA indication.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
A 'Suspected LVO' priority notification with compressed preview images through mobile application/email and a web user-interface path with unprocessed/straightened images; notified clinicians must review non-compressed images on a diagnostic viewer.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Compressed previews are informational and not diagnostic beyond notification; the device is limited to imaging-data analysis, does not replace full patient evaluation, and must not be relied on to make or confirm diagnosis. The device does not mark a specific image location or alter/remove/deprioritize the original worklist case.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K231837
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Brain/head vasculature, specifically terminal ICA and MCA-M1
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-09-28
  • 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 packet describes a DICOM-compliant software package on an off-the-shelf physical or virtual server integrated with the Brainomix 360 Platform, receiving data from DICOM-compliant imaging devices and providing mobile-app and web-user-interface notifications; exact local interface versions and compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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 2026-09-09

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 2026-09-09

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 2026-09-09

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

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Brainomix 360 Triage LVO; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
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 packet: standalone retrospective evaluation of 308 CTA scans from 14 U.S. hospitals/clinics, with two ABR-certified neuroradiologists and a third adjudicator. The confusion matrix was TP 126, TN 156, FP 12, FN 14; overall sensitivity was 90.0% (95% CI 84.2%-94.3%), specificity 92.9% (88.0%-94.3%), and ROC AUC 91.4% (88.2%-94.5%). Time-to-notification ranged from 86.3 to 178.2 seconds against a 3.5-minute goal; left/right hemisphere and other subgroup endpoints are separate.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Overall standalone LVO endpoint: 90.0% (95% CI 84.2%-94.3%); left-hemisphere subgroup 88.6% (79.4%-94.8%) and right-hemisphere subgroup 91.4% (83.0%-96.7%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The overall and hemisphere subgroup sensitivities are labeled separately; ROC AUC and time-to-notification remain distinct.

Reported specificity
Overall standalone LVO endpoint: 92.9% (95% CI 88.0%-94.3%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

This is the overall FDA specificity; subgroup specificity values must not be collapsed into the directory fact.

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

Brainomix 360 Triage LVO regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K231837
  • Samplen=308
  • Sites14
  • IndependenceIndependence not established

K231837

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 2026-09-09

No public price or quote for the exact K231837 configuration was established in this review.

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

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 K231837. 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 2026-09-09

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
2026-09-09Last 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 K231837: Brainomix 360 Triage LVO

    U.S. Food and Drug Administration - Published 2023-09-28 - Accessed 2026-09-09

    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. Brainomix 360 Triage LVO model card (K231837)

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

    Scope: intendedUsers, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, 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 K231837

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

    Scope: postmarketSafety

Research history

  1. K231837 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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