Radiology AI Directory

FDA-cleared profile

EFAI NeuroSuite CT ICH Assessment System

Ever Fortune.AI Co., Ltd.

Authorized purpose: Case-level prioritization and passive notification for adult non-contrast head CT studies with features suggestive of acute intracranial hemorrhage (ICH); not a stand-alone diagnostic or rule-out tool.

Stroke and ICH triageAcute 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: Case-level prioritization and passive notification for adult non-contrast head CT studies with features suggestive of acute intracranial hemorrhage (ICH); not a stand-alone diagnostic or rule-out tool.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Case-level prioritization and passive notification for adult non-contrast head CT studies with features suggestive of acute intracranial hemorrhage (ICH); not a stand-alone diagnostic or rule-out tool.

Evidence takeaway

Evidence from the reviewed source record: FDA packet: retrospective, blinded, multisite validation of 288 CT studies (132 ICH positive, 156 negative) from 23 U.S. clinical sites, with three U.S. board-certified neuroradiologists and majority ground truth; the lower bounds of both 95% CIs were required to exceed 0.8. Standalone sensitivity was 0.947 (95% CI 0.895-0.974), specificity 0.949 (0.902-0.974), AUROC 0.983 (0.969-0.997), and mean processing time 34.96 seconds (33.89-36.03). Subgroup analyses covered demographic, manufacturer, slice-thickness, and ICH-type groups without replacing the overall 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 prioritization and passive notification for adult non-contrast head CT studies with features suggestive of acute intracranial hemorrhage (ICH); not a stand-alone diagnostic or rule-out tool.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Radiologists and trained clinicians.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Adult non-contrast head-CT triage workflow through a PACS/workstation; the FDA packet does not specify a narrower facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Passive case-level triage/notification and worklist prioritization with no image-region marking or direction of attention.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DICOM-compliant adult non-contrast head CT studies with features suggestive of acute ICH.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Binary case-level 'Suspected ICH: Yes or No' output to a PACS/workstation for worklist prioritization or triage; the device does not mark, highlight, or direct attention to a specific image location.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Not intended to address anomalies other than acute ICH, direct attention to image portions, provide stand-alone clinical decision-making, rule out hemorrhage, or preclude assessment of the CT study; full clinical review remains required.
  • 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
K231025
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Brain/head
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-10-04
  • 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 FDA packet describes DICOM-compliant input and case-level output to a PACS/workstation; exact interface versions, routing behavior, and local compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

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.

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 NeuroSuite CT ICH Assessment System; 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, multisite validation of 288 CT studies (132 ICH positive, 156 negative) from 23 U.S. clinical sites, with three U.S. board-certified neuroradiologists and majority ground truth; the lower bounds of both 95% CIs were required to exceed 0.8. Standalone sensitivity was 0.947 (95% CI 0.895-0.974), specificity 0.949 (0.902-0.974), AUROC 0.983 (0.969-0.997), and mean processing time 34.96 seconds (33.89-36.03). Subgroup analyses covered demographic, manufacturer, slice-thickness, and ICH-type groups without replacing the overall endpoints.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Standalone adult non-contrast head-CT ICH endpoint: 0.947 (95% CI 0.895-0.974).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

This is the overall FDA validation sensitivity; the 0.8 value is the lower-bound acceptance goal, not sensitivity.

Reported specificity
Standalone adult non-contrast head-CT ICH endpoint: 0.949 (95% CI 0.902-0.974).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

This is the overall FDA validation specificity; AUROC and processing time are separate endpoints.

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

EFAI NeuroSuite CT ICH Assessment System regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K231025
  • Samplen=288
  • Sites23
  • IndependenceIndependence not established

K231025

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 K231025 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 K231025. 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
25Fields 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 K231025: EFAI NeuroSuite CT ICH Assessment System

    U.S. Food and Drug Administration - Published 2023-10-04 - 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. EFAI NeuroSuite CT ICH Assessment System model card (K231025)

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

    Scope: intendedUsers, careSetting, output, limitations, 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 K231025

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

    Scope: postmarketSafety

Research history

  1. K231025 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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