Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 or intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the triage of images acquired from adult patients in the acute setting, within 24 hours of the onset of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect symmetrical bilateral MCA occlusions. Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile application. Notifications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
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 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 or intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the triage of images acquired from adult patients in the acute setting, within 24 hours of the onset of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect symmetrical bilateral MCA occlusions. Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile application. Notifications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
Public source Exact FDA submission Checked 2026-09-01
Exact-submission indication text from the ACR AI Central model card. FDA labeling remains controlling.
CT images or data. Inclusion criteria: Non-contrast head CT (NCCT) images acquired from adult patients in the acute setting, within 24 hours of the onset of acute symptoms, or where this is unclear, since last known well (LKW) time. Images from Siemens, GE, and Philips scanners.
Public source Exact FDA submission Checked 2026-09-01
Conservative normalization of explicit wording in an exact-submission source.
The device outputs a priority notification to clinicians indicating suspicion of ICH or LVO based on positive findings. Specifically: Triage ICH Module flags suspected ICH; NCCT LVO Module flags suspected LVO; Triage Stroke Module flags suspected ICH or LVO. Notifications are delivered via web user interface or mobile application and include compressed preview images for informational purposes only. The device does not mark or highlight specific locations in the original image.
Public source Exact FDA submission Checked 2026-09-01
Clinical output reported in the exact-submission ACR model card.
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
K251983
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Public source Exact FDA submission Checked 2026-08-13
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
Cloud-based and on-premises deployment are explicitly described in the exact-submission ACR model card; hosting region, data flow, and current commercial configuration require vendor confirmation.
Public source Exact FDA submission Checked 2026-09-01
Deployment mode explicitly reported in the exact-submission ACR model card; hosting region and current commercial configuration still require vendor confirmation.
Vendor confirmation Exact FDA submission Checked 2026-08-13
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-08-13
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Deployment model
Cloud-based and on-premises deployment are explicitly described in the exact-submission ACR model card; hosting region, data flow, and current commercial configuration require vendor confirmation.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Brainomix 360 Triage Stroke regulatory performance study summary
Stand-alone performance and reader study (ACR AI Central category) · Adult
exact submission · Tested version: Exact product version not reported; regulatory study summarized for FDA submission K251983 · n=608 · Independence not established
K251983
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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 2026-08-13
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-08-31
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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 2026-09-02
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: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
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.
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-02Last searched
20Fields reviewed
6Source classes checked
0Unreviewed PubMed leads
0Unreviewed 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. 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, pubmed, clinical trials, openfda device recall
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...