Rapid CTA 360 analyzes adult head CTA DICOM images to flag suspected large- and medium-vessel occlusion in specified intracranial and vertebral segments and notify trained clinicians for workflow triage; notifications are informational and not diagnostic.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
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
Rapid CTA 360 analyzes adult head CTA DICOM images to flag suspected large- and medium-vessel occlusion in specified intracranial and vertebral segments and notify trained clinicians for workflow triage; notifications are informational and not diagnostic.
Trained clinicians and stroke teams who review head CTA triage notifications and the source examination; a notification does not replace professional judgment or diagnosis.
Parallel radiological triage and notification to surface suspected vessel occlusion for clinician attention; it does not alter the original study or provide a diagnosis.
Suspected occlusion triage notifications, reports, and DICOM Secondary Capture or compressed preview content for clinician workflow; the original CT study is not changed.
The software is for triage and notification, not diagnosis or primary image interpretation. Notifications are informational, can be delayed or absent, and require review of the original CTA by qualified clinicians. The validated sensitivity and specificity apply to the FDA-described adult datasets and vessel definitions.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The exact system receives adult head CTA DICOM studies, processes them in parallel with standard reading, and sends notifications and DICOM Secondary Capture or preview outputs; local PACS/RIS routing, notification channels, downtime, and escalation require acceptance testing.
The FDA packet describes server or standalone desktop deployment with workflow notifications; the reviewed exact materials do not establish current hosting topology, service availability, retention, or infrastructure terms for a particular installation.
The FDA packet describes an OWASP risk process, annual ISO 27001/27701 certification, and UL-2900-1 conformance as part of the reviewed security evidence; current certificate scope, expiry, deployed configuration, and operational controls require confirmation.
FDA source
Exact FDA submission
Checked 2026-09-07
This records the exact FDA packet's described evidence and is not a current independent security attestation.
Trained clinicians must review notifications against the original CTA and understand that the output is triage-only; local onboarding should cover covered vessel segments, notification failure and delay, escalation, and downtime procedures.
The exact submission processes head CTA in parallel with standard reading and sends workflow notifications while leaving the original study unchanged; test notification latency, delivery, escalation, and downtime locally.
RapidAI describes Rapid CTA as automatically processing CTA to assess reduced blood flow, identify and locate suspected large- or distal-vessel occlusion, and notify stroke teams for transfer decisions.
product family · checked 2026-09-07
Current family workflow page; it does not establish every feature, vessel scope, or deployment term for the K251151 release.
The FDA packet describes DICOM Secondary Capture and compressed preview or notification outputs; establish local PACS storage, mobile/web or other notification channels, retention, and clinician acknowledgement procedures.
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
K251151 FDA evidence is a regulatory head-CTA triage and notification validation; no independent paper or trial was promoted in this timeboxed review.
DesignRetrospective regulatory development, test, and independent validation of computer-aided head-CTA triage and notification against three-expert reference review.
PopulationDevelopment/test corpus of 6,264 cases from 133 sites; final independent validation of 403 adult CTA examinations across scanner vendors with three-expert 2-of-3 reference review.
Scopeexact submission
Tested versionRapid CTA 360 configuration described in K251151
Samplen=403
Sites133
IndependenceSponsor or vendor study
K251151
Manufacturer-submitted FDA evidence; the 403-case test set is independent of development but the overall evidence is regulatory, 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 K251151 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 neurovascular triage 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 K251151. This does not establish absence of family, later-version, or adverse-event information.
Verify pricing and total cost: No public list price or contract unit for the exact K251151 configuration was established in the reviewed official sources.
Verify reimbursement and coding relevance: CMS plaque-policy review was not applied to this neurovascular triage 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
0Screened PubMed leads
0Screened 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 product page, fda device recall, literature index, trial registry, stored candidate metadata, 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 history8 sources - 2 history items
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