Radiology AI Directory

FDA-cleared profile

BriefCase-Triage

Aidoc Medical, Ltd.

Authorized purpose: Adult head CTA or mCTA triage for suspected complete large-vessel and medium-vessel occlusion.

Acute triage and notification
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 head CTA or mCTA triage for suspected complete large-vessel and medium-vessel occlusion.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Adult head CTA or mCTA triage for suspected complete large-vessel and medium-vessel occlusion.

Evidence takeaway

Evidence from the reviewed source record: FDA retrospective, blinded, multicenter mCTA VO performance study using ground truth from 2+1 U.S. board-certified radiologist reviewers. Primary endpoint: sensitivity 81.4% (95% CI 71.6-89.0) and specificity 85.5% (95% CI 78.0-91.2). Secondary endpoints: NPV 97.6%, PPV 38.4%, PLR 5.6, NLR 0.22, and time-to-notification 1.09 minutes versus 2.23 minutes for the predicate. The FDA packet does not state the study sample size or site count.

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 head CTA or mCTA triage for suspected complete large-vessel and medium-vessel occlusion.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Hospital networks and appropriately trained medical specialists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Hospital imaging networks using a parallel radiology workflow for patients aged 18 and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Notification-only triage and worklist prioritization in parallel with standard of care; cases remain in the standard reading queue.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Filtered DICOM head CTA or mCTA images; adults or transitional adults aged 18 and older; clinical-testing slice thickness 0.5-1.25 mm.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
A pop-up notification and compressed, low-quality, grayscale, unannotated preview labeled not for diagnostic use and for prioritization only, identifying a suspected VO finding; the clinician reviews the original images in PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not a diagnostic device; inadequate field of view is excluded; the packet supports head CTA/mCTA inputs and full-image clinician review, not diagnosis from the preview.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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.

FDA submission
K261317
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Head/Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-05-14
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

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/routing module and sends analysis to a desktop feed and non-diagnostic image viewer for PACS follow-up; exact current interfaces and versions are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

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 2026-09-08
Source

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 mCTA VO performance study using ground truth from 2+1 U.S. board-certified radiologist reviewers. Primary endpoint: sensitivity 81.4% (95% CI 71.6-89.0) and specificity 85.5% (95% CI 78.0-91.2). Secondary endpoints: NPV 97.6%, PPV 38.4%, PLR 5.6, NLR 0.22, and time-to-notification 1.09 minutes versus 2.23 minutes for the predicate. The FDA packet does not state the study sample size or site count.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
81.4% (95% CI: 71.6%, 89%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
85.5% (95% CI: 78%, 91.2%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

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-Vessel Occlusion LVO & MeVO Triage regulatory performance study summary

  • DesignRegulatory performance study summarized by ACR AI Central
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K261317
  • IndependenceIndependence not established

K261317

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K261317 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K261317. 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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

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

  1. FDA K261317: BriefCase-Triage

    U.S. Food and Drug Administration - Published 2026-05-14 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. BriefCase-Vessel Occlusion LVO & MeVO Triage model card (K261317)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K261317

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K261317 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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