Brainomix 360 e-CTA analyzes adult CTA brain DICOM for vessel visualization and post-processing, including MCA vessel-density asymmetry, contrast/phase context, overlays, and MIP views, for trained clinical review; it is not for mobile diagnosis and its vessel-density asymmetry ratio is limited to the MCA region.
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
Brainomix 360 e-CTA analyzes adult CTA brain DICOM for vessel visualization and post-processing, including MCA vessel-density asymmetry, contrast/phase context, overlays, and MIP views, for trained clinical review; it is not for mobile diagnosis and its vessel-density asymmetry ratio is limited to the MCA region.
FDA source Exact FDA submission Checked 2026-09-07
CTA visualization and analysis support for reviewing hemispheric vessel-density differences, contrast intensity, estimated phase, and registered overlays; the results support but do not replace trained clinical interpretation.
FDA source Exact FDA submission Checked 2026-09-07
Visualization and post-processing outputs including registration, MIP views, a colored overlay of the MCA hemisphere with lower vessel density, relative vessel-density asymmetry, contrast-intensity measurements, and estimated phase; results can be sent to PACS or viewed through a hospital-network web interface, while email previews are compressed informational attachments.
FDA source Exact FDA submission Checked 2026-09-07
The vessel-density asymmetry ratio applies only to the MCA region. Brainomix 360 e-CTA is not intended for mobile diagnostic use. Email previews are compressed and for informational notification only; clinicians must view non-compressed images on a diagnostic viewer and complete appropriate patient evaluation before care-related decisions.
FDA source Exact FDA submission Checked 2026-09-07
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
K242123
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The exact submission can receive CTA scans from a PACS through DICOM, send results and images to PACS through DICOM, and expose results through a web interface on a machine within the hospital network and firewall; local routing, worklist, email, viewer, and failure behavior require acceptance testing.
FDA source Exact FDA submission Checked 2026-09-07
The exact submission runs on standard off-the-shelf physical or virtual server hardware and is accessed through a hospital network and firewall or LAN connection; the reviewed sources do not establish the current site-specific hosting, storage, retention, availability, or service-level arrangement.
FDA source Exact FDA submission Checked 2026-09-07
Reviewed sources checked Exact FDA submission Checked 2026-09-07
The reviewed exact packet and official family FAQ do not establish current scoped security controls, encryption, PHI flow, retention, access control, audit, vulnerability management, or incident response for the installed K242123 release.
Training and support
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-07
The FDA indication requires trained professionals; the official FAQ describes family training but does not establish an exact K242123 curriculum or competency assessment.
Monitoring and change control
Monitor CTA transfer and protocol eligibility, MCA-only interpretation of vessel-density asymmetry, image-quality and registration failures, compressed-preview versus diagnostic-viewer use, PACS/web/email delivery, failed or repeated analyses, reader overrides, downtime, updates, complaints, and exact-submission recalls.
FDA source Exact FDA submission Checked 2026-09-07
Buyer acceptance guidance derived from the exact FDA workflow and validation scope; it is not a claimed vendor monitoring service.
Brainomix's current FAQ says Brainomix 360 Stroke results are typically available within 1-2 minutes and delivered via PACS, email, mobile app, or web browser; it supports major scanner and PACS manufacturers through standard DICOM and engineers test connections before go-live. This is family-level context and does not establish exact K242123 latency or configuration.
Brainomix's current FAQ describes a managed appliance on virtualized cloud or physical hardware, with vendor-led installation, scanner/PACS connection, protocol setup, and go-live testing alongside hospital IT; it also describes group training and multilingual manuals for clinical users. Exact K242123 terms and curriculum were not established.
The FDA packet describes DICOM transfer to and from PACS, hospital-network web viewing, and compressed email previews that are not diagnostic; confirm local routing, diagnostic-viewer access, notification policy, and failure recovery during qualification.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
K242123 FDA evidence is a retrospective standalone manufacturer-submitted validation of vessel delineation and parenchyma masking on 308 brain CTA scans; all cases were processed successfully. No independent paper or trial was promoted in this timeboxed review.
FDA source Exact FDA submission Checked 2026-09-07
Retrospective standalone performance study comparing AI/ML vessel delineation and parenchyma masking with the stated reference process across clinical CTA scans. · 308 US brain CTA scans: 179 from Boston Medical Centre or referring Massachusetts hospitals and 129 from Mayo Clinic Rochester; scanners included Siemens, GE, Philips, and Canon/Toshiba systems, with demographic, site, scanner, and stenosis stratifications.
exact submission · Tested version: Brainomix 360 e-CTA configuration described in K242123 · n=308 · Sponsor or vendor study
K242123
Manufacturer-submitted FDA evidence; the named clinical sources do not make this an independent investigator study.
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 FDA submission Checked 2026-09-07
No public list price or exact contract unit for K242123 was established in the reviewed official sources.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-07
No payer-policy research was applied to this dossier; product-specific coverage or claim eligibility is not established.
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-submission FDA recall query returned no native recall record for K242123. This is not a comprehensive safety clearance and does not exclude family, later-version, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-07
Verify security and privacy controls: The reviewed exact packet and official family FAQ do not establish current scoped security controls, encryption, PHI flow, retention, access control, audit, vulnerability management, or incident response for the installed K242123 release.
Verify training: The FDA indication requires trained professionals; the official FAQ describes family training but does not establish an exact K242123 curriculum or competency assessment.
Verify pricing and total cost: No public list price or exact contract unit for K242123 was established in the reviewed official sources.
Verify reimbursement and coding relevance: No payer-policy research was applied to this dossier; product-specific coverage or claim eligibility is not established.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
11Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
The stored PubMed and ClinicalTrials.gov candidate arrays were screened and were empty. No paper or trial was promoted; empty stored arrays do not establish that no external literature or trials exist. 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 documentation, fda device recall, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall
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