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-Triage
Aidoc Medical, Ltd.
Authorized purpose: Parallel-workflow triage and notification of suspected incidental pulmonary embolism on contrast-enhanced images that include the lungs.
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: Parallel-workflow triage and notification of suspected incidental pulmonary embolism on contrast-enhanced images that include the lungs.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Parallel-workflow triage and notification of suspected incidental pulmonary embolism on contrast-enhanced images that include the lungs.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Chest and lungs Input: Filtered DICOM contrast-enhanced images that include the lungs, including single- and dual-energy exams, from adults or transitional adolescents aged 18 or older, with axial slice thickness of 0.5-5.0 mm; studies with inadequate field of view are excluded.
- Who uses it? Intended users: Hospital networks and appropriately trained medical specialists; notified clinicians review the original images
- What does the software produce? Output: A pop-up notification for a suspected incidental pulmonary embolism case and a compressed, low-quality, grayscale, unannotated preview labeled not for diagnostic use and for prioritization only; users must open the original full images in the PACS.
- What is its most important limitation? Key limitation: The preview is informational and not for diagnosis; the device does not alter original images, mark findings, remove cases from the standard-of-care queue, or independently determine diagnosis. The labeled/validated input is adult or transitional adolescent age 18 or older contrast-enhanced lung-containing imaging, with inadequate field of view excluded.
Clinical takeaway
Clinical role: Parallel-workflow triage and notification of suspected incidental pulmonary embolism on contrast-enhanced images that include the lungs.
Evidence takeaway
Evidence from the reviewed source record: FDA packet: retrospective blinded multicenter pivotal study of 498 cases from six U.S. clinical sites with ground truth from three senior board-certified radiologists. Primary endpoints were sensitivity and specificity against an 80% performance goal; default sensitivity was 91.7% and specificity 91.4%. The secondary time-to-notification endpoint was 40.2 seconds versus 282 seconds for the predicate; PPV was 22.2%, NPV 99.8%, PLR 10.7, and NLR 0.09.
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
- Parallel-workflow triage and notification of suspected incidental pulmonary embolism on contrast-enhanced images that include the lungs.
- Intended users
- Hospital networks and appropriately trained medical specialists; notified clinicians review the original images
- Care setting and population
- Hospital-network radiology worklist and acute-care triage workflow
- Workflow role
- Notification-only, parallel worklist prioritization that does not remove or deprioritize cases from standard-of-care review
- Required input
- Filtered DICOM contrast-enhanced images that include the lungs, including single- and dual-energy exams, from adults or transitional adolescents aged 18 or older, with axial slice thickness of 0.5-5.0 mm; studies with inadequate field of view are excluded.
- Output and human action
- A pop-up notification for a suspected incidental pulmonary embolism case and a compressed, low-quality, grayscale, unannotated preview labeled not for diagnostic use and for prioritization only; users must open the original full images in the PACS.
- Limitations
- The preview is informational and not for diagnosis; the device does not alter original images, mark findings, remove cases from the standard-of-care queue, or independently determine diagnosis. The labeled/validated input is adult or transitional adolescent age 18 or older contrast-enhanced lung-containing imaging, with inadequate field of view excluded.
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
- The algorithm module runs on a Linux-based server in a cloud environment and integrates with image-communication platforms meeting the input/output requirements, a desktop image-review application, DICOM/PACS workflow, and a notification path; the packet describes de-identification, cloud upload, analysis, and return of the notification.
- 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-Triage; 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
- FDA packet: retrospective blinded multicenter pivotal study of 498 cases from six U.S. clinical sites with ground truth from three senior board-certified radiologists. Primary endpoints were sensitivity and specificity against an 80% performance goal; default sensitivity was 91.7% and specificity 91.4%. The secondary time-to-notification endpoint was 40.2 seconds versus 282 seconds for the predicate; PPV was 22.2%, NPV 99.8%, PLR 10.7, and NLR 0.09.
- Reported sensitivity
- 91.7% (95% CI: 87.5%, 94.9%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 91.4% (95% CI: 87.3%, 94.6%)
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 for iPE regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K250248
- Samplen=498
- Sites6
- IndependenceIndependence not established
K250248
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 K250248 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 K250248. 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 K250248 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
26Fields 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, 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
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FDA K250248: BriefCase-Triage
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
BriefCase-Triage for iPE model card (K250248)
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 K250248
Scope: postmarketSafety
Research history
-
K250248 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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