Radiology AI Directory

FDA-cleared profile

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

Ever Fortune.AI, Co., Ltd.

Authorized purpose: Prioritization and triage of non-contrast head CT cases with features suggestive of midline shift in individuals aged 18 years and older.

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

Authorized purpose: Prioritization and triage of non-contrast head CT cases with features suggestive of midline shift in individuals aged 18 years and older.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Prioritization and triage of non-contrast head CT cases with features suggestive of midline shift in individuals aged 18 years and older.

Evidence takeaway

Evidence from the reviewed source record: FDA retrospective, blinded, multisite validation used 300 US cases (102 positive and 198 negative) with majority ground truth from three US board-certified radiologists. The dataset included multiple CT manufacturers and a mean age of 59.46 years. Standalone sensitivity was 0.961 (95% CI: 0.903-0.985), specificity was 0.955 (95% CI: 0.916-0.973), AUROC was 0.983 (95% CI: 0.967-0.996), and mean processing time was 62.04 seconds (95% CI: 60.65-63.44); subgroup analyses were also performed.

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
Prioritization and triage of non-contrast head CT cases with features suggestive of midline shift in individuals aged 18 years and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Radiologists
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Passive case-level notification and worklist prioritization in parallel with standard-of-care interpretation; the device does not mark a location or triage findings other than MLS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Non-contrast head CT studies from individuals aged 18 years and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Case-level passive notification available to a PACS/workstation for worklist prioritization when suspected MLS is identified; no preview image or marking of a specific location is provided.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The device is limited to non-contrast head CT and suspected MLS in individuals aged 18 and older, with no user control to select other findings. Results are not for standalone clinical decision-making and are not intended to rule out MLS or preclude clinical assessment. The packet describes on-premise deployment without cloud-server interfacing.
  • 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
K241923
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Head/brain, for suspected midline shift (MLS)
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-12-06
  • 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 device sends case-level notification to a PACS/RIS workstation for worklist prioritization and is deployed only on-premise; the packet states that it does not interface with cloud servers and does not establish a specific local interface or protocol.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
Hybrid
  • 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.

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 Midline Shift Assessment System (MLS-CT-100); 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 retrospective, blinded, multisite validation used 300 US cases (102 positive and 198 negative) with majority ground truth from three US board-certified radiologists. The dataset included multiple CT manufacturers and a mean age of 59.46 years. Standalone sensitivity was 0.961 (95% CI: 0.903-0.985), specificity was 0.955 (95% CI: 0.916-0.973), AUROC was 0.983 (95% CI: 0.967-0.996), and mean processing time was 62.04 seconds (95% CI: 60.65-63.44); subgroup analyses were also performed.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Standalone case-level sensitivity for suspected midline shift on non-contrast head CT: 0.961 (95% CI: 0.903-0.985).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

FDA reports this endpoint for the 300-case multisite validation, separately from specificity, AUROC, processing time, and subgroup analyses.

Reported specificity
Standalone case-level specificity for suspected midline shift on non-contrast head CT: 0.955 (95% CI: 0.916-0.973).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

FDA reports this endpoint separately from sensitivity, AUROC, processing time, and subgroup analyses.

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

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K241923
  • Samplen=300
  • IndependenceIndependence not established

K241923

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 K241923 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 K241923. 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 K241923: EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

    U.S. Food and Drug Administration - Published 2024-12-06 - 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 Midline Shift Assessment System (MLS-CT-100) model card (K241923)

    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 K241923

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

    Scope: postmarketSafety

Research history

  1. K241923 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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