Brainomix 360 e-ASPECTS registers adult non-contrast brain CT, segments ASPECTS regions, and provides an editable ASPECTS score with highlighted regions and voxel contribution views to assist trained clinicians evaluating suspected ischemic stroke within 24 hours of last known well.
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-ASPECTS registers adult non-contrast brain CT, segments ASPECTS regions, and provides an editable ASPECTS score with highlighted regions and voxel contribution views to assist trained clinicians evaluating suspected ischemic stroke within 24 hours of last known well.
FDA source Exact FDA submission Checked 2026-09-07
Trained clinicians evaluating suspected acute ischemic stroke; the output is assistive, editable, and not a replacement for primary image interpretation or clinical judgment.
FDA source Exact FDA submission Checked 2026-09-07
Automated ASPECTS registration, region segmentation, and decision-support visualization for clinician review of suspected ischemic stroke; it is not a primary diagnostic interpretation or mobile diagnostic result.
FDA source Exact FDA submission Checked 2026-09-07
Adult non-contrast brain CT DICOM images for suspected acute ischemic stroke within 24 hours of last known well; the FDA validation was tied to specified Siemens Somatom Definition scanner configurations.
FDA source Exact FDA submission Checked 2026-09-07
ASPECTS score from 0 to 10, highlighted ASPECTS regions, affected side and regions, voxel heatmap/contribution views, affected voxel volume, and editable clinician-reviewed results delivered through the configured workstation or PACS workflow.
FDA source Exact FDA submission Checked 2026-09-07
The tool is not a primary interpretation, does not provide a mobile diagnostic result, and requires clinician review and editing. The FDA intended population excludes hemorrhagic transformation or hematoma and is tied to adult patients within 24 hours of last known well; the validation scanner scope was limited and later versions or other scanners require confirmation.
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
K243294
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 accepts brain CT DICOM through a standalone server or physical/virtual server, sends results to PACS or its web interface, and can provide compressed previews through configured channels; local DICOM routing, scanner compatibility, PACS behavior, and acknowledgement require acceptance testing.
FDA source Exact FDA submission Checked 2026-09-07
The FDA packet describes standalone off-the-shelf physical or virtual server deployment with DICOM transfer to PACS and a web interface; it does not establish current hosting region, retention, availability, service terms, or the installed infrastructure configuration.
FDA source Exact FDA submission Checked 2026-09-07
Brainomix's current official FAQ describes ISO 27001, GDPR, and DPA controls for the current Brainomix 360 family; this does not establish certificate scope, expiry, deployed configuration, or exact K243294 security controls.
Public source Product family Checked 2026-09-07
Obtain current certificate scope, data-processing terms, hosting region, encryption, identity/access, audit, retention, and incident-response evidence for the deployed release.
Trained clinicians must review and may edit ASPECTS results; Brainomix's current family FAQ says clinical users receive group training, but exact K243294 training materials and competency evidence were not established.
Public source Product family Checked 2026-09-07
Confirm exact release training, local competency, and escalation procedures.
Monitor eligible scanner and CT protocol inputs, registration and ASPECTS edits, discordance with primary reading, result delivery and acknowledgement, downtime, updates, complaints, and recalls by exact K243294 release.
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 official FAQ describes Brainomix 360 support for major scanner and PACS manufacturers using DICOM, with engineers testing connections before go-live; confirm exact K243294 scanner scope and local interface behavior.
product family · checked 2026-09-07
Current family FAQ; it does not establish every current feature or deployment term for the K243294 release.
The current family FAQ says clinicians can review and edit ASPECTS and that edits are labelled; local acceptance should verify edit provenance, PACS/web delivery, and the distinction between compressed previews and diagnostic source images.
product family · checked 2026-09-07
Current family workflow context; exact K243294 implementation and configuration require confirmation.
The exact FDA submission describes physical or virtual server deployment with DICOM transfer and PACS/web result delivery; test scanner eligibility, series routing, processing latency, result acknowledgement, and downtime procedures.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
K243294 FDA evidence is a regulatory ASPECTS segmentation and reader-assistance validation of Brainomix 360 e-ASPECTS; no independent paper or trial was promoted in this timeboxed review.
FDA source Exact FDA submission Checked 2026-09-07
Retrospective regulatory validation of ASPECTS registration and segmentation plus a multi-reader multi-case comparison with and without software assistance. · Standalone validation of 137 non-contrast head CT scans from three U.S. institutions; MRMC reader comparison of 140 scans by seven readers.
exact submission · Tested version: Brainomix 360 e-ASPECTS configuration described in K243294 · n=140 · 3 sites · Sponsor or vendor study
K243294
Manufacturer-submitted FDA evidence; the reader comparison is regulatory evidence, not an independent clinical-outcome 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 contract unit for the exact K243294 configuration was established in the reviewed official sources.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-07
CMS plaque-policy review was not applied to this stroke dossier; no product-specific coverage determination is made.
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 wave22 exact-submission recall query returned no native recall record for K243294. This does not establish absence of family, later-version, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-07
Verify pricing and total cost: No public list price or contract unit for the exact K243294 configuration was established in the reviewed official sources.
Verify reimbursement and coding relevance: CMS plaque-policy review was not applied to this stroke dossier; no product-specific coverage determination is made.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
26Fields 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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