Radiology AI Directory

FDA-cleared profile

EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)

Ever Fortune.Ai, Co., Ltd.

Authorized purpose: Triage notification of suspected appendicitis on contrast-enhanced abdominal CT

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: Triage notification of suspected appendicitis on contrast-enhanced abdominal CT

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Triage notification of suspected appendicitis on contrast-enhanced abdominal CT

Evidence takeaway

Evidence from the reviewed source record: Retrospective blinded multisite study of 300 consecutive US CTs, 139 positive and 161 negative, with three board-certified radiologists and majority reference. Mean processing time was 3.37 minutes in the study, not a service-level commitment.

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
Triage notification of suspected appendicitis on contrast-enhanced abdominal CT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Hospital networks and trained clinicians
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
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
Triage or notification support
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
Contrast-enhanced abdominal CT DICOM images
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Case-level text/JSON notification to PACS/RIS/workstation; no DICOM viewer, image overlay, location marking, worklist reprioritization or removal.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
Not a diagnostic device and does not alter the original image. Clinicians must review full images and all patient information under standard care.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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
K253163
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Anatomy
Abdomen
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-04-22
  • 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
Passive JSON notification into PACS/RIS workstation workflow
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Hosting and local network topology were not established.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

No scoped dated security attestation reviewed.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Site triage escalation and notification training are unestablished.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Site audit of alert delivery and missed/false alerts requires confirmation.

Vendor emergency-imaging context

Vendor positions CT-based AI assistance for emergency and radiology workflows.

product family ยท checked 2026-09-06

Page does not establish APPEN-CT-100-specific interfaces or performance.

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
Retrospective blinded multisite study of 300 consecutive US CTs, 139 positive and 161 negative, with three board-certified radiologists and majority reference. Mean processing time was 3.37 minutes in the study, not a service-level commitment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported sensitivity
92.8% (95% CI 87.3%-96.0%)
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported specificity
93.2% (95% CI 88.2%-96.1%)
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Sensitivity

92.8 %

  • EndpointSuspected appendicitis case triage
  • Population300 consecutive US contrast-enhanced abdominal CTs
  • Tested versionAPPEN-CT-100 in K253163
Source

Specificity

93.2 %

  • EndpointSuspected appendicitis case triage
  • Population300 consecutive US contrast-enhanced abdominal CTs
  • Tested versionAPPEN-CT-100 in K253163
Source

K253163 appendicitis triage standalone study

  • DesignRetrospective blinded multisite standalone performance study
  • Population300 consecutive US CTs; 139 appendicitis-positive, 161 negative
  • Scopeexact submission
  • Tested versionAPPEN-CT-100
  • Samplen=300
  • IndependenceIndependence not established

K253163

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 2026-09-06

No exact product price/procurement record reviewed.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-06

No applicable payer policy reviewed.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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.

Human reviewedStatus
2026-09-06Last searched
21Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored PubMed and clinical-trial arrays are empty and were screened. 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, acr ai central product, fda decision summary, vendor product page, literature index, trial registry, recall database, 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. K253163 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) model card (K253163)

    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. EFAI ERSUITE CT Appendicitis Assessment System: K253163 decision and 510(k) summary

    U.S. Food and Drug Administration - Accessed 2026-09-05

    Scope: identity, clinical, evidence, implementation

  8. Ever Fortune AI medical imaging solutions

    Ever Fortune.AI - Accessed 2026-09-06

    Scope: implementation

Research history

  1. K253163 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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