FDA-cleared profile

BriefCase-Triage

Aidoc Medical, Ltd.

Authorized purpose: Case-level triage and notification of suspected central pulmonary embolism on CTPA in adults or transitional adolescents aged 18 years and older, in parallel with standard-of-care interpretation.

Pulmonary embolism 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

Overview status: Source-reviewed overview

What does this software do? Authorized purpose: Case-level triage and notification of suspected central pulmonary embolism on CTPA in adults or transitional adolescents aged 18 years and older, in parallel with standard-of-care interpretation.
Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Chest and central pulmonary arteries Input: Filtered DICOM CTPA images from adults or transitional adolescents aged 18 years and older; the algorithm processes the series chronologically.
Who uses it? Intended users: Hospital networks and appropriately trained medical specialists.
What does the software produce? Output: A pop-up/priority notification for suspected central PE with a compressed, low-quality, grayscale, unannotated preview labeled for prioritization only; the workflow prompts review of the original images in PACS.
What is its most important limitation? Key limitation: The preview is informational and not for diagnostic use beyond notification; the original image is not altered, cases are not removed or deprioritized, and clinicians must review full images with other patient information and professional judgment. The FDA packet does not specify an additional image-quality or slice-thickness exclusion.

Clinical takeaway

Clinical role: Case-level triage and notification of suspected central pulmonary embolism on CTPA in adults or transitional adolescents aged 18 years and older, in parallel with standard-of-care interpretation.

Evidence takeaway

Evidence from the reviewed source record: FDA packet: retrospective, blinded, multicenter pivotal study of 328 unique cases from 6 U.S. clinical sites, with three senior board-certified radiologists using majority voting. Default sensitivity was 89.2% (95% CI 82.5%-93.9%) and specificity 94.5% (90.3%-97.2%) against an 80% goal. AOP1 sensitivity/specificity were 96.9% (92.3%-99.2%)/85.9% (80.3%-90.4%). Default time-to-notification was 29.3 seconds (95% CI 26.8-31.9; n=115); PPV 52.9%, NPV 99.2%, PLR 16.1, and NLR 0.1 are separate endpoints.

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: Case-level triage and notification of suspected central pulmonary embolism on CTPA in adults or transitional adolescents aged 18 years and older, in parallel with standard-of-care interpretation.

Intended users: Hospital networks and appropriately trained medical specialists.

Care setting and population: Hospital-network clinical triage workflow for adults or transitional adolescents aged 18 years and older.

Workflow role: Parallel case-level triage and notification/worklist prioritization for suspected central PE; cases remain in the standard-of-care queue.

Required input: Filtered DICOM CTPA images from adults or transitional adolescents aged 18 years and older; the algorithm processes the series chronologically.

Output and human action: A pop-up/priority notification for suspected central PE with a compressed, low-quality, grayscale, unannotated preview labeled for prioritization only; the workflow prompts review of the original images in PACS.

Limitations: The preview is informational and not for diagnostic use beyond notification; the original image is not altered, cases are not removed or deprioritized, and clinicians must review full images with other patient information and professional judgment. The FDA packet does not specify an additional image-quality or slice-thickness exclusion.

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: K232751

Modality: CT/CTA

Anatomy: Chest and central pulmonary arteries

Clearance type: 510(k)

Decision date: 2023-10-30

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: The FDA packet describes a Linux-based cloud server receiving filtered DICOM images, an algorithm module integrated with a compatible image-communication platform and desktop workflow application, and review of original images in PACS; exact local interface compatibility is not established.

Deployment and data flow: On-cloud

Security and privacy: Vendor documentation pending

Training and support: Vendor documentation pending

Monitoring and change control: Vendor documentation pending

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Result destination

PACS is explicitly referenced as a result destination.

exact submission · checked 2026-09-01

Confirm supported products, versions, routing behavior, and display requirements during local evaluation.

Source

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-Triage; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09

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 packet: retrospective, blinded, multicenter pivotal study of 328 unique cases from 6 U.S. clinical sites, with three senior board-certified radiologists using majority voting. Default sensitivity was 89.2% (95% CI 82.5%-93.9%) and specificity 94.5% (90.3%-97.2%) against an 80% goal. AOP1 sensitivity/specificity were 96.9% (92.3%-99.2%)/85.9% (80.3%-90.4%). Default time-to-notification was 29.3 seconds (95% CI 26.8-31.9; n=115); PPV 52.9%, NPV 99.2%, PLR 16.1, and NLR 0.1 are separate endpoints.

Reported sensitivity: Default operating point: 89.2% (95% CI 82.5%-93.9%); AOP1 additional operating point: 96.9% (95% CI 92.3%-99.2%).

Reported specificity: Default operating point: 94.5% (95% CI 90.3%-97.2%); AOP1 additional operating point: 85.9% (95% CI 80.3%-90.4%).

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

BriefCase-Central Pulmonary Embolism Triage regulatory performance study summary

DesignStand-Alone Performance
PopulationAdult
Scopeexact submission
Tested versionExact product version not reported; regulatory study summarized for FDA submission K232751
Samplen=328
Sites6
IndependenceIndependence not established

K232751

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

Reimbursement and coding: Not established in reviewed sources

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 K232751. 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 K232751 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.

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

2026-09-20Last 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

FDA K232751: BriefCase-Triage

U.S. Food and Drug Administration - Published 2023-10-30 - Accessed 2026-09-09

Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
Artificial Intelligence-Enabled Medical Devices

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

Scope: regulatoryIdentity, modalityContext
BriefCase-Central Pulmonary Embolism Triage model card (K232751)

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

Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
PubMed biomedical literature index

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

Scope: evidenceDiscovery
ClinicalTrials.gov study registry

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

Scope: evidenceDiscovery, studyStatus
openFDA Device Recall API

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

Scope: recallDiscovery, nativeSubmissionMatching
openFDA exact recall query for K232751

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

Scope: postmarketSafety

Research history

2023-10-30

K232751 FDA decision

Regulatory record

510(k)
2026-09-20

Source-review record updated

Research record

fda record reviewed
2026-09-20

Reader overview source-reviewed

Editorial review

Source-reviewed editorial overlay

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