Radiology AI Directory

FDA-cleared profile

Brainomix 360 Triage ICH

Brainomix Limited

Provide notification-only parallel workflow triage of adult non-contrast brain CT studies acquired in the acute setting within 24 hours of symptom onset or since last known well when onset is unclear, notifying a specialist when intracranial hemorrhage is suspected.

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
Provide notification-only parallel workflow triage of adult non-contrast brain CT studies acquired in the acute setting within 24 hours of symptom onset or since last known well when onset is unclear, notifying a specialist when intracranial hemorrhage is suspected.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Hospital networks and trained clinicians, including neurovascular or neurosurgical specialists who receive and review the notification.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Hospital/clinical acute-care environment and existing patient pathways; adult acute cases within the specified symptom-onset or last-known-well window.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Parallel, notification-only study triage that recommends specialist review without removing or deprioritizing cases from the standard worklist.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Non-contrast brain CT images from adult acute-care patients within 24 hours of acute-symptom onset or since last known well when unclear; the FDA packet states validation and intended use on GE and Philips scanners.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Priority notification or a suspected-hemorrhage flag to clinicians, accessible through a web interface and mobile application, with compressed preview images for informational notification only; notified clinicians must view non-compressed images on a diagnostic viewer.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Not for mobile diagnostic use, isolated subarachnoid hemorrhage, recent neurosurgery or endovascular neurointervention within 6 weeks, or prior intracranial hemorrhage within 4 weeks. Not suitable for scan data with tumors or abscesses, coils, shunts, embolization, movement artifacts, or specified intracranial vascular pathologies. Results do not replace full patient evaluation or diagnosis.
  • 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
K231195
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-07-27
  • 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 package on a standard physical or virtual server within a hospital-network workflow, with mobile and web notification channels; exact current PACS/RIS/EHR interfaces, versions, and local compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-premise
  • 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 ICH; 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
Retrospective standalone testing used 341 non-contrast CT studies from 30 U.S. hospitals and clinics; all cases were processed. Ground truth used experienced U.S. board-certified neuroradiologists. The confusion matrix was TP 149, TN 159, FP 15, FN 18, yielding overall sensitivity (positive percentage agreement) 89.22% and specificity (negative percentage agreement) 91.37%. Subgroup endpoints include ICH subtype, gender, age, slice thickness, site, and hemorrhage volume. A separate time-to-notification analysis reported 50-126 seconds; the FDA primary acceptance criterion was 80% sensitivity and specificity.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Acute intracranial-hemorrhage standalone sensitivity (positive percentage agreement, TP/[TP+FN]) in 341 adult non-contrast brain CT studies: 89.22% (TP 149, FN 18); the FDA text does not state an overall confidence interval for this value.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The FDA endpoint is bounded to acute adult NCCT ICH notification and is distinct from the 80% prespecified acceptance criterion, subtype sensitivity, and 50-126-second notification interval.

Reported specificity
Acute intracranial-hemorrhage standalone specificity (negative percentage agreement, TN/[TN+FP]) in 341 adult non-contrast brain CT studies: 91.37% (TN 159, FP 15); the FDA text does not state an overall confidence interval for this value.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The FDA endpoint is bounded to acute adult NCCT ICH notification and is distinct from the 80% prespecified acceptance criterion and subgroup endpoints.

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

Brainomix 360 Triage ICH regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K231195
  • Samplen=341
  • Sites30
  • IndependenceIndependence not established

K231195

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 K231195 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 K231195. 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
25Fields 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 K231195: Brainomix 360 Triage ICH

    U.S. Food and Drug Administration - Published 2023-07-27 - 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 ICH model card (K231195)

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

    Scope: intendedUsers, careSetting, 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 K231195

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

    Scope: postmarketSafety

Research history

  1. K231195 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

Alternatives

Related tools to compare

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
FDA-cleared K250685

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-06-16
Stroke and ICH triageAcute triage and notification