Supported acquisition environment
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exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
FDA-cleared profile
BriefCase
Aidoc Medical, Ltd.
Authorized 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.
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: 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.
Overview status: Source-reviewed overview
- What does this software do? Authorized 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.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Brain/Cerebrovascular Input: CT/CTA images or data involving Brain/Cerebrovascular; consult the FDA labeling for exact protocol, series, and quality requirements.
- Who uses it? Intended users: Hospital networks and appropriately trained medical specialists
- What does the software produce? Output: 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.
- What is its most important limitation? Key limitation: Head CTA protocol with a 64-slice scanner or higher; scans performed on adults/transitional adults ≥ 18 years of age; slice thickness 0.5 mm – 1.25 mm. All scans that are technically inadequate, including motion artifacts, severe metal artifacts, suboptimal bolus timing or an inadequate field of view.
Clinical takeaway
Clinical role: 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.
Evidence takeaway
Evidence from the reviewed source record: Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase software to evaluate the software's performance in identifying head CTA images containing Vessel Occlusion (VO) in 342 cases from 5 US-based clinical sites. Ground truth was determined by 3 expert US board certified Neurologists reviewers using majority voting. Sensitivity was 91.3% (95% CI: 83.6%, 96.2%) and specificity was 85.6% (95% CI: 80.6%, 89.7%).
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.
- Intended users
- Hospital networks and appropriately trained medical specialists
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Triage or notification support
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.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- 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.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Limitations
- Head CTA protocol with a 64-slice scanner or higher; scans performed on adults/transitional adults ≥ 18 years of age; slice thickness 0.5 mm – 1.25 mm. All scans that are technically inadequate, including motion artifacts, severe metal artifacts, suboptimal bolus timing or an inadequate field of view.
The exact packet's comparison table states the inclusion and exclusion boundary and slice thickness for the subject device.
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
- Modality
- CT/CTA
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Anatomy
- Brain/Cerebrovascular
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Clearance type
- 510(k)
- Decision date
- 2022-10-07
- FDA status
- FDA-cleared
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.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- On-cloud
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
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.
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 2026-09-08Evidence
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
- Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase software to evaluate the software's performance in identifying head CTA images containing Vessel Occlusion (VO) in 342 cases from 5 US-based clinical sites. Ground truth was determined by 3 expert US board certified Neurologists reviewers using majority voting. Sensitivity was 91.3% (95% CI: 83.6%, 96.2%) and specificity was 85.6% (95% CI: 80.6%, 89.7%).
The exact packet reports the retrospective multicenter study, ground-truth review, and primary endpoint metrics.
- Reported sensitivity
- 91.3% (95% CI: 83.6%, 96.2%)
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%)
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.
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 K220709 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 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.
Buyer worksheet
Open questions to take to the vendor
- 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 K220709 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
2026-09-20Last searched
27Fields reviewed
10Source classes checked
20Screened PubMed leads
6Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 20 PubMed and 6 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 20 PubMed and 6 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, fda device recall, literature index, trial registry, fda decision summary packet, 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
-
FDA K220709: BriefCase
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
BriefCase-Vessel Occlusion LVO & MeVO Triage model card (K220709)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K220709
Scope: postmarketSafety
Research history
-
K220709 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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