Family implementation support
Managed-appliance deployment, PACS protocol setup and go-live testing are described by the vendor.
product family · checked 2026-09-05FDA-cleared profile
Brainomix 360 Hyperdensity
Brainomix Limited
Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
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.
- Intended users
- Medical imaging professionals (trained clinicians) in a hospital/clinical environment
Intended-user text reported in the exact-submission ACR model card.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Segmentation or contouring
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- Adult single-timepoint non-contrast head CT.
- Output and human action
- RGB overlay segmentation, summary DICOM series and hyperdensity volumes; overlay colors and volumes have no standalone clinical meaning.
- Limitations
- Does not provide lateral-ventricle volume or midline shift and is not a replacement for physician image review.
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.
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.
- Deployment and data flow
- Software may be deployed as a physical server or virtual-machine software appliance.
- Security and privacy
- Vendor documentation pending
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.
- 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.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- Regulatory segmentation agreement testing is submission-specific; clinical diagnostic-performance metrics were not abstracted.
- Reported sensitivity
- Not established in reviewed sources
- Reported specificity
- Not established in reviewed sources
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
Segmentation validation against trained-radiologist reference. · Adult non-contrast CT; cohort size not reported in the reviewed summary.
exact submission · Tested version: Brainomix 360 Hyperdensity configuration K260406 · Independence not establishedK260406
Economics and lifecycle
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
- Reimbursement and coding
- Research pending
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
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
- Verify security and privacy controls: No scoped and dated security evidence was reviewed.
- Verify pricing and total cost.
- Verify reimbursement and coding relevance: No applicable payer policy reviewed.
- Verify recalls and postmarket safety signals: 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.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-06Last searched
22Fields reviewed
9Source classes checked
0Reviewed PubMed leads
0Reviewed 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, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-05.
- K260406 FDA decision source U.S. Food and Drug Administration · 2026-08-31
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- Brainomix 360 Hyperdensity model card (K260406) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
- Brainomix 360 Hyperdensity: K260406 clearance and 510(k) summary US Food and Drug Administration · 2026-09-05
- Brainomix support and trust-center FAQ Brainomix · 2026-09-05
Alternatives
Related tools to compare
FDA-cleared K243378
Rapid MLS
iSchemaview Inc.
Brain midline-shift measurement on adult non-contrast CT
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-05-28
FDA-cleared K161322
CT CoPilot
ZEPMED, LLC.
CT CoPilotTM is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2016-12-07
FDA-cleared K253818
Annalise Enterprise
Harrison-AI Medical Pty, Ltd.
Annalise Enterprise prioritizes and notifies trained CT clinicians of suspected acute infarct on non-contrast brain CT for adults; it is a study-level, non-localizing worklist aid...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2026-03-03
FDA-cleared K250694
Scaida BrainCT-ICH (v1.0)
Mlhealth 360
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-11-25