Radiology AI Directory

FDA-cleared profile

BriefCase-Triage

Aidoc Medical, Ltd.

Authorized purpose: Workflow triage and notification of suspect cases with three or more acute rib-fracture (RibFx) pathologies in adults or transitional adolescents aged 18 and older.

MSK and boneAcute 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: Workflow triage and notification of suspect cases with three or more acute rib-fracture (RibFx) pathologies in adults or transitional adolescents aged 18 and older.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Workflow triage and notification of suspect cases with three or more acute rib-fracture (RibFx) pathologies in adults or transitional adolescents aged 18 and older.

Evidence takeaway

Evidence from the reviewed source record: FDA pivotal testing was retrospective, blinded, and multicenter: 308 cases from five US clinical sites were compared with ground truth from three senior board-certified radiologists. The standalone study-level AUC was 97.2% (95% CI: 95.5%-99.0%), sensitivity was 95.2% (95% CI: 89.1%-98.4%), and specificity was 95.1% (95% CI: 91.2%-97.6%). A separate secondary endpoint measured mean time to notification at 41.4 seconds (95% CI: 40.4-42.5) for 104 true-positive cases; four additional operating points were also reported, so these metrics are not one universal operating point.

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
Workflow triage and notification of suspect cases with three or more acute rib-fracture (RibFx) pathologies in adults or transitional adolescents aged 18 and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Appropriately trained medical specialists; the device is intended to support hospital-network workflow triage
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Hospital networks and parallel standard-of-care radiology workflow
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Parallel preemptive case triage, notification, and worklist prioritization; full images remain the standard of care and the preview is not diagnostic.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Filtered DICOM CT images with or without contrast that include the ribs, from adults or transitional adolescents aged 18 and older; clinical testing used single-energy exams on scanners with at least 64 detectors and 0.5-5.0 mm axial slices.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
A pop-up notification in the desktop image-review software with a compressed, low-quality, grayscale preview captioned for prioritization only; the preview has no finding markings, and the original study remains in the standard-of-care PACS workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The device is not diagnostic and the preview is informational only; notified clinicians must view the full images. Testing excluded technically inadequate studies, including motion artifacts, severe metal artifacts, and inadequate field of view, and was bounded by single-energy, 64-detector, 0.5-5.0 mm axial-slice, and adult/transitional-adolescent criteria.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K243548
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Ribs
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-12-11
  • 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
The software runs on a Linux-based cloud server, receives filtered DICOM images through an image communication platform, processes series chronologically, and sends a notification to a desktop image-review application for PACS/worklist prioritization. A specific local PACS interface is not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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 2026-09-09

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 2026-09-09

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 2026-09-09

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-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 pivotal testing was retrospective, blinded, and multicenter: 308 cases from five US clinical sites were compared with ground truth from three senior board-certified radiologists. The standalone study-level AUC was 97.2% (95% CI: 95.5%-99.0%), sensitivity was 95.2% (95% CI: 89.1%-98.4%), and specificity was 95.1% (95% CI: 91.2%-97.6%). A separate secondary endpoint measured mean time to notification at 41.4 seconds (95% CI: 40.4-42.5) for 104 true-positive cases; four additional operating points were also reported, so these metrics are not one universal operating point.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Standalone study-level sensitivity for three-or-more acute rib-fracture findings: 95.2% (95% CI: 89.1%-98.4%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

FDA reports this subject-device primary endpoint separately from AUC, time-to-notification, and the four additional operating points.

Reported specificity
Standalone study-level specificity for three-or-more acute rib-fracture findings: 95.1% (95% CI: 91.2%-97.6%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

FDA reports this subject-device primary endpoint separately from AUC, timing, and additional operating-point values.

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

BriefCase-Triage for RibFx regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K243548
  • Samplen=308
  • Sites5
  • IndependenceIndependence not established

K243548

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 2026-09-09

No public price or quote for the exact K243548 configuration was established in this review.

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

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 K243548. 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 2026-09-09

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
2026-09-20Last 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

  1. FDA K243548: BriefCase-Triage

    U.S. Food and Drug Administration - Published 2024-12-11 - Accessed 2026-09-09

    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-Triage for RibFx model card (K243548)

    American College of Radiology - Published 2026-08-17 - 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 K243548

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

    Scope: postmarketSafety

Research history

  1. K243548 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

Alternatives

Related tools to compare

FDA-cleared K253578

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

Aidoc Medical, Ltd.

BriefCase-Triage CARE Multi-Triage CT analyzes contrast and non-contrast chest, abdomen, or chest/abdomen CT in adults or transitional adolescents aged 18 and older to flag...

Modality
CT/CTA
Anatomy
Chest and abdomen; pneumothorax, pericardial effusion, large aortic aneurysm, and shoulder fracture/dislocation
Decision
2026-02-26
MSK and boneAcute triage and notification
FDA-cleared K240942

CINA-CSpine

Avicenna.AI

Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization;...

Modality
CT/CTA
Anatomy
Cervical spine; acute cervical-spine fractures including non-displaced lines and displaced fragments
Decision
2024-09-12
MSK and boneDetection and CADeAcute triage and notification