Radiology AI Directory

FDA-cleared profile

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)

Ever Fortune.AI, Co., Ltd.

Passive triage of adult AP chest radiographs for an endotracheal-tube tip more than 7 cm above the carina, less than 3 cm above the carina, below the carina in the right or left mainstem, or other listed malposition states.

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.

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
Passive triage of adult AP chest radiographs for an endotracheal-tube tip more than 7 cm above the carina, less than 3 cm above the carina, below the carina in the right or left mainstem, or other listed malposition states.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Intended users
Radiologists and other qualified healthcare professionals reviewing adult AP chest radiographs in acute-care settings.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Care setting and population
Hospital and acute-care imaging workflows where adult AP chest radiographs are used to assess endotracheal-tube position.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Workflow role
Notification-only case-level triage for a malpositioned single-lumen ETT; it is not a standalone diagnostic or rule-out system.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Required input
Adult AP chest X-ray in DICOM with a single-lumen endotracheal tube.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Output and human action
Case-level text/JSON result sent to PACS or a workstation for worklist triage; no image markup is added.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Limitations
The software does not assess esophageal intubation, may issue a false alert for a properly positioned double-lumen ETT, does not account for patient position, and does not replace clinician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

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
K242821
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Anatomy
Chest/Lung
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-02-20
  • 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 result is transmitted as a case-level text/JSON notification to PACS or a workstation for passive worklist triage.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Deployment and data flow
Software connected to DICOM imaging workflow; the public FDA summary does not establish the customer's hosting, routing or support topology.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

The reviewed family platform page does not establish exact-release security controls, retention or assurance documentation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Case-level PACS/workstation triage

The cleared system returns text/JSON case results for worklist triage and does not add image markup.

exact submission · checked 2026-09-07
Source

ChestSuite worklist workflow

The current EverFortune.AI ChestSuite page describes four chest findings in a single pass, AI-flagged studies surfaced to the top of the worklist and pre-annotated findings before radiologist review.

product family · checked 2026-09-07

This family description does not establish the exact K242821 hosting, DICOM connector or service contract.

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
The FDA-described retrospective, blinded, multisite study included 940 AP chest radiographs from 940 patients: 259 positive and 681 negative by a majority reference of three U.S. board-certified radiologists. Sensitivity was 0.890, specificity 0.935 and reported processing time 2.49 minutes.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Reported sensitivity
0.89
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

Exact-submission AP-only retrospective study.

Reported specificity
0.935
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

Exact-submission AP-only retrospective study.

ETT malposition sensitivity

0.89 proportion

  • EndpointSensitivity
  • Population940 adult AP chest radiographs: 259 positive and 681 negative by the FDA reference standard
  • Tested versionETT-XR-100 configuration submitted in K242821
Source

ETT malposition specificity

0.935 proportion

  • EndpointSpecificity
  • Population940 adult AP chest radiographs: 259 positive and 681 negative by the FDA reference standard
  • Tested versionETT-XR-100 configuration submitted in K242821
Source

ETT malposition processing time

2.49 minutes

  • EndpointReported processing time
  • Population940 adult AP chest radiographs in the FDA-described study
  • Tested versionETT-XR-100 configuration submitted in K242821
Source

ETT-XR-100 malposition assessment study

  • DesignRetrospective, blinded, multisite study with majority reference from three U.S. board-certified radiologists
  • Population940 adult AP chest radiographs from 940 patients, including 259 positive and 681 negative cases
  • Scopeexact submission
  • Tested versionETT-XR-100 configuration submitted in K242821
  • Samplen=940
  • IndependenceSponsor or vendor study

K242821

FDA reports sensitivity 0.890, specificity 0.935 and processing time 2.49 minutes. Subgroups included gender, age, race, manufacturers and confounders.

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 2026-09-07

No public price or quote for ETT-XR-100 was reviewed.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-07

Payer policy research was not part of this worker's scope.

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 2026-09-07

The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

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
2026-09-07Last searched
24Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored candidate metadata was screened; no PubMed or trial IDs were returned for this submission. This is not a full-paper review. 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, vendor product page, stored candidate metadata, 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 510(k) K242821: EFAI Chestsuite XR Malpositioned ETT Assessment System

    U.S. Food and Drug Administration - Accessed 2026-09-07

    Scope: identity, purpose, clinicalUse, modality, anatomy, workflowRole, intendedUsers, careSetting, input, output, limitations, integration, deployment, reportedSensitivity, reportedSpecificity, evidenceMetrics, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) model card (K242821)

    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. ChestSuite | EverFortune.AI

    EverFortune.ai - Accessed 2026-09-07

    Scope: productFamilyContext, clinicalUse, implementationCapabilities

Research history

  1. K242821 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

Alternatives

Related tools to compare

FDA-cleared K243808

Rayvolve PTX-PE

AZmed

Passive study-level worklist triage for suspected pneumothorax and/or pleural effusion on adult PA or AP chest X-rays; it is not a proactive specialist alert.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2025-03-21
Acute triage and notification
FDA-cleared K232410

SmartChest

Milvue

Passive worklist prioritization for suspected pleural effusion and/or pneumothorax on frontal PA or AP chest radiographs in transitional adolescents aged 18-21 and adults aged 22...

Modality
X-ray/Radiography
Anatomy
Chest/lung
Decision
2024-05-10
Acute triage and notification
FDA-cleared K231871

Radify Triage

Envisionit DeepAI Ltd

Passively triage adult frontal chest X-rays for suspected pleural effusion and/or pneumothorax by providing case-level PACS worklist output; not a standalone clinical-decision...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2024-01-17
Acute triage and notification