Radiology AI Directory

FDA-cleared profile

BriefCase

Aidoc Medical, Ltd.

Notification-only triage of adult head CTA for suspected complete large-vessel and medium-vessel occlusions; compressed previews are informational and the full study remains required for diagnosis.

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.

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
Notification-only triage of adult head CTA for suspected complete large-vessel and medium-vessel occlusions; compressed previews are informational and the full study remains required for diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Hospital networks and appropriately trained medical specialists
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Intended-user text reported in the exact-submission ACR model card.

Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Triage or notification support
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
CT/CTA images or data involving Brain/Cerebrovascular; consult the FDA labeling for exact protocol, series, and quality requirements.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Output and human action
The AI model flags and sends notifications for suspected positive findings of Large Vessel Occlusion (LVO) and Medium Vessel Occlusions (MeVO) in head CTA images. Notifications include compressed, low-quality, grayscale, unannotated preview images for informational/triage purposes only (not for diagnostic use). The device prioritizes suspect cases on the worklist to facilitate earlier triage.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Clinical output reported in the exact-submission ACR model card.

Limitations
Exclusion criteria: All scans that are technically inadequate, including motion artifacts, severe metal artifacts, suboptimal bolus timing or an inadequate field of view.. Scanner manufacturers: All. Slice thickness: Slice thickness 0.5 mm – 1.25 mm
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Limitations and supported-acquisition details reported in the exact-submission ACR model card.

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
K220709
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain/Cerebrovascular
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-10-07
  • 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
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.

Deployment and data flow
On-cloud
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

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.

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for BriefCase; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · 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
Study type: Stand-Alone Performance. Cases: 342. Sites: 5. Reference standard: Interpretation by Reviewing Clinician. Reported sensitivity: 91.3% (95% CI: 83.6%, 96.2%). Reported specificity: 85.6% (95% CI: 80.6%, 89.7%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.

Reported sensitivity
91.3% (95% CI: 83.6%, 96.2%)
  • 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
85.6% (95% CI: 80.6%, 89.7%)
  • 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

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K220709
  • Samplen=342
  • Sites5
  • IndependenceIndependence not established

K220709

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 K220709 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 K220709. 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
2026-09-08Last searched
25Fields reviewed
9Source classes checked
20Awaiting review PubMed leads
6Awaiting review 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. Exact FDA scope controls clinical claims. ACR and official vendor material provide bounded catalog or product-family context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 20 PubMed and 6 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, 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 K220709: BriefCase

    U.S. Food and Drug Administration - Published 2022-10-07 - 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 (K220709)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

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

  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 K220709

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

    Scope: postmarketSafety

Research history

  1. K220709 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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

Modality
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Acute triage and notification