Radiology AI Directory

FDA-cleared profile

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

Ever Fortune.AI, Co., Ltd.

Authorized purpose: Assist hospital networks and appropriately trained medical specialists in triaging adults aged 22 years and older by flagging suspected aortic dissection or aortic intramural hematoma on chest or chest-abdomen CTA.

CT/CTA workflow
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: Assist hospital networks and appropriately trained medical specialists in triaging adults aged 22 years and older by flagging suspected aortic dissection or aortic intramural hematoma on chest or chest-abdomen CTA.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Assist hospital networks and appropriately trained medical specialists in triaging adults aged 22 years and older by flagging suspected aortic dissection or aortic intramural hematoma on chest or chest-abdomen CTA.

Evidence takeaway

Evidence from the reviewed source record: FDA K240291 reports a retrospective, blinded, multisite validation of 380 consecutively collected US CTA studies, including 156 positives and 224 negatives, independent of model development and analytical validation. Three US board-certified radiologists established ground truth by majority agreement. Sensitivity was 0.929 (95% CI 0.878-0.960) and specificity was 0.915 (95% CI 0.871-0.945). The secondary system-processing endpoint was 37.86 seconds per study (95% CI 35.22-40.50).

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
Assist hospital networks and appropriately trained medical specialists in triaging adults aged 22 years and older by flagging suspected aortic dissection or aortic intramural hematoma on chest or chest-abdomen CTA.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Hospital networks and appropriately trained medical specialists
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Hospital networks / acute-care radiology workflow
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Notification-only parallel triage and worklist prioritization; the device flags cases for earlier review without marking a location or replacing clinical assessment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM chest or chest-abdomen CTA studies from adults aged 22 years and older; the FDA validation set included 380 CTA studies with 156 positive and 224 negative cases.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Case-level passive notification or flag to a PACS/workstation indicating suspected aortic dissection or aortic intramural hematoma; the device does not mark, highlight, or direct attention to a specific image location.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The output is for worklist prioritization or triage, not standalone clinical decision-making. It is not intended to rule out acute aortic syndrome or preclude clinical assessment of CTA cases, and it does not provide lesion marking or location-specific guidance.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K240291
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Chest, abdomen, and thoracoabdominal aorta
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-04-08
  • 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 packet describes DICOM input and passive output to a PACS/RIS workstation for worklist prioritization or triage. Specific interface versions, current deployment, and local compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-premise
  • 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.

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 and workstation are 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

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM; 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
FDA K240291 reports a retrospective, blinded, multisite validation of 380 consecutively collected US CTA studies, including 156 positives and 224 negatives, independent of model development and analytical validation. Three US board-certified radiologists established ground truth by majority agreement. Sensitivity was 0.929 (95% CI 0.878-0.960) and specificity was 0.915 (95% CI 0.871-0.945). The secondary system-processing endpoint was 37.86 seconds per study (95% CI 35.22-40.50).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
92.90%
  • 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
91.50%
  • 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.

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K240291
  • Samplen=380
  • IndependenceIndependence not established

K240291

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 K240291 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 K240291. 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
2026-09-20Last searched
24Fields 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 K240291: EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

    U.S. Food and Drug Administration - Published 2024-04-08 - 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. EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM model card (K240291)

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

    Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, 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 K240291

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

    Scope: postmarketSafety

Research history

  1. K240291 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

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