Radiology AI Directory

FDA-cleared profile

Brainomix 360 Hyperdensity

Brainomix Limited

Authorized purpose: Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.

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.

Product overview

Start with the essentials

Authorized purpose: Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.

Evidence takeaway

Evidence from the reviewed source record: Regulatory segmentation agreement testing is submission-specific; clinical diagnostic-performance metrics were not abstracted.

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
Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
Medical imaging professionals and trained clinicians.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact packet identifies medical imaging professionals as primary users and the intended environment/users as trained clinicians.

Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Segmentation or contouring
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
Adult single-timepoint non-contrast head CT.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Output and human action
DICOM summary and segmentation series with RGB overlays and hyperdensity volume labels; colors are only for visual differentiation between segmented regions and have no meaning on their own.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact device description states the DICOM series, RGB overlay, volume-label, and color-meaning boundaries.

Limitations
Does not provide lateral-ventricle volume or midline shift and is not a replacement for physician image review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

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
K260406
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact packet identifies non-contrast CT as the supported imaging modality. Controlled directory display reconciled from exact FDA wording: Non-Contrast CT (NCCT). -> CT/CTA.

Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact comparison table identifies Head as the anatomical region. Controlled directory display reconciled from exact FDA wording: Head. -> Brain.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-06-12
  • 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
Automated DICOM routing sends original images and results to preconfigured PACS destinations; the DICOM Network Integration Module uses DICOM C-STORE.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Deployment and data flow
Software may be deployed as a physical server or virtual-machine software appliance.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact product version
  • Checked 2026-09-05

No scoped and dated security evidence was reviewed.

Training and support
Current Brainomix FAQ describes installation/go-live testing and group training/manuals for licensed users.
  • Vendor supplied
  • Product family
  • Checked 2026-09-05
Monitoring and change control
The PCCP permits model retraining and threshold adjustment within the cleared indications; models are locked before release and do not continuously learn.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Family implementation support

Managed-appliance deployment, PACS protocol setup and go-live testing are described by the vendor.

product family ยท checked 2026-09-05
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
Regulatory segmentation agreement testing is submission-specific; clinical diagnostic-performance metrics were not abstracted.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05
Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

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

Brainomix 360 Hyperdensity regulatory segmentation validation

  • DesignSegmentation validation against trained-radiologist reference.
  • PopulationAdult non-contrast CT; cohort size not reported in the reviewed summary.
  • Scopeexact submission
  • Tested versionBrainomix 360 Hyperdensity configuration K260406
  • IndependenceIndependence not established

K260406

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact product version
  • Checked 2026-09-06
Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-06

No applicable payer policy reviewed.

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.

Exact FDA record reviewedStatus
2026-09-19Last searched
24Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

No stored literature or trial candidates; empty metadata snapshots were screened. 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, acr ai central product, fda decision summary, vendor product page, literature index, trial registry, fda decision summary packet, 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 K260406: Brainomix 360 Hyperdensity

    U.S. Food and Drug Administration - Published 2026-06-12 - Accessed 2026-09-19

    Scope: purpose, input, limitations, modality, anatomy, intendedUsers, output, evidenceSummary, clinicalUse

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Brainomix 360 Hyperdensity model card (K260406)

    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. Brainomix 360 Hyperdensity: K260406 clearance and 510(k) summary

    US Food and Drug Administration - Accessed 2026-09-05

    Scope: identity, clinical, implementation, evidence

  8. Brainomix support and trust-center FAQ

    Brainomix - Accessed 2026-09-05

    Scope: product_family_implementation

Research history

  1. K260406 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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