ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for BriefCase-Triage; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission ยท checked 2026-09-08FDA-cleared profile
BriefCase-Triage
Aidoc Medical, Ltd.
Authorized purpose: Adult contrast-enhanced brain CT triage for suspected brain aneurysm findings at least 3.0 mm.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Adult contrast-enhanced brain CT triage for suspected brain aneurysm findings at least 3.0 mm.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Adult contrast-enhanced brain CT triage for suspected brain aneurysm findings at least 3.0 mm.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Brain Input: Filtered DICOM contrast-enhanced CT images including the brain; adults or transitional adults aged 18 and older; 0.5-2.5 mm axial slices.
- Who uses it? Intended users: Hospital networks and appropriately trained medical specialists.
- What does the software produce? Output: A pop-up notification and compressed, low-quality, grayscale, unannotated preview labeled not for diagnostic use and for prioritization only when a suspected brain aneurysm at least 3.0 mm is flagged.
- What is its most important limitation? Key limitation: Not a diagnostic device; inadequate field of view is excluded; the FDA testing input range was 0.5-2.5 mm axial slices; the preview has no finding marking and full PACS images must be reviewed.
Clinical takeaway
Clinical role: Adult contrast-enhanced brain CT triage for suspected brain aneurysm findings at least 3.0 mm.
Evidence takeaway
Evidence from the reviewed source record: FDA retrospective, blinded, multicenter pivotal study: 544 cases from six U.S. clinical sites, with ground truth from three senior board-certified radiologists and test data distinct from training. Primary sensitivity was 87.8% (95% CI 83.1-91.6) and specificity 91.6% (87.9-94.5). Secondary results included NPV 98.9%, PPV 47.6%, PLR 10.5, NLR 0.13, and mean time-to-notification 44.8 seconds (95% CI 41.4-48.2; n=241) versus 252 seconds for the predicate; the timing measure was calculated for true-positive cases.
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
- Adult contrast-enhanced brain CT triage for suspected brain aneurysm findings at least 3.0 mm.
- Intended users
- Hospital networks and appropriately trained medical specialists.
- Care setting and population
- Hospital imaging networks using a parallel radiology workflow for patients aged 18 and older.
- Workflow role
- Notification-only triage and worklist prioritization in parallel with standard of care; full images remain the diagnostic source.
- Required input
- Filtered DICOM contrast-enhanced CT images including the brain; adults or transitional adults aged 18 and older; 0.5-2.5 mm axial slices.
- Output and human action
- A pop-up notification and compressed, low-quality, grayscale, unannotated preview labeled not for diagnostic use and for prioritization only when a suspected brain aneurysm at least 3.0 mm is flagged.
- Limitations
- Not a diagnostic device; inadequate field of view is excluded; the FDA testing input range was 0.5-2.5 mm axial slices; the preview has no finding marking and full PACS images must be reviewed.
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
- Linux-based cloud server receives filtered DICOM through an image communication platform and sends results to a desktop feed/non-diagnostic viewer for review of the original PACS images; exact current interfaces and versions are not established.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Evidence
Performance evidence
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
- FDA retrospective, blinded, multicenter pivotal study: 544 cases from six U.S. clinical sites, with ground truth from three senior board-certified radiologists and test data distinct from training. Primary sensitivity was 87.8% (95% CI 83.1-91.6) and specificity 91.6% (87.9-94.5). Secondary results included NPV 98.9%, PPV 47.6%, PLR 10.5, NLR 0.13, and mean time-to-notification 44.8 seconds (95% CI 41.4-48.2; n=241) versus 252 seconds for the predicate; the timing measure was calculated for true-positive cases.
- Reported sensitivity
- 87.8% (95% CI: 83.1%, 91.6%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 91.6% (95% CI: 87.9%, 94.5%)
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
BriefCase-Triage Brain Aneurysm regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested version2
- Samplen=544
- Sites6
- IndependenceIndependence not established
K251195
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
No public price or quote for the exact K251195 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
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-identifier FDA recall query returned no native recall record for K251195. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K251195 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-19Last searched
23Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. 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, fda device recall, literature index, trial registry, 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 history
Source ledger
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FDA K251195: BriefCase-Triage
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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BriefCase-Triage Brain Aneurysm model card (K251195)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K251195
Scope: postmarketSafety
Research history
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K251195 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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