Radiology AI Directory

FDA-cleared profile

Lung AI (LAI001)

Exo Inc

Lung AI LAI001 assists trained healthcare professionals performing point-of-care lung ultrasound by detecting and visualizing pleural effusion and consolidation or atelectasis in lung ultrasound cine clips.

Detection and CADeUltrasound 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.

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
Lung AI LAI001 assists trained healthcare professionals performing point-of-care lung ultrasound by detecting and visualizing pleural effusion and consolidation or atelectasis in lung ultrasound cine clips.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Trained and qualified healthcare professionals performing point-of-care ultrasound in emergency-department workflows; the FDA labeling does not include EMTs or military medics.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Emergency-department point-of-care lung-ultrasound workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Frame-level visualization aid for lung-ultrasound findings at the PLAPS point.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Lung ultrasound cine clips acquired during the BLUE protocol PLAPS point.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
One region of interest per clip frame showing the largest detected finding for visualization; no patient-level aggregation is provided.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The FDA labeling states that Lung AI is not a clinical diagnosis, does not replace provider judgment or standard tests, and was not designed or tested for EMTs or military medics. CT or X-ray remains required when standard of care calls for it.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
K243239
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Lung; pleural effusion and consolidation or atelectasis at the PLAPS point
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-04-24
  • 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 package describes post-processing integrated by a programmer into a third-party ultrasound device and displayed in the existing ultrasound interface without a built-in viewer.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Deployment and data flow
The FDA package describes integration into a third-party ultrasound device; current device configuration, hosting, security, availability, and service boundaries remain unknown.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Use by trained and qualified healthcare professionals performing point-of-care ultrasound in emergency-department workflows; the fda labeling does not include emts or military medics. Follow the exact labeling, local training, supervision, and escalation requirements.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K243239.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Release and scope verification

Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K243239.

exact submission · checked 2026-09-04
Source

Deployment boundary

The FDA package describes integration into a third-party ultrasound device; current device configuration, hosting, security, availability, and service boundaries remain unknown.

exact submission · checked 2026-09-04
Source

Interoperability acceptance

The FDA package describes post-processing integrated by a programmer into a third-party ultrasound device and displayed in the existing ultrasound interface without a built-in viewer.

exact submission · checked 2026-09-04
Source

Clinical acceptance

Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K243239.

exact submission · checked 2026-09-04
Source

Economic evaluation

Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.

product family · checked 2026-09-04
Source

Lifecycle monitoring

Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.

exact submission · checked 2026-09-04
SourceSource

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
K243239 FDA decision material reports the exact evidence metrics included below for Lung AI LAI001; values are limited to the stated endpoint, population, and operating point.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Pleural Effusion: 97% (95% CI: 94%, 99%) , Consolidation/Atelectasis: 97% (95% CI: 94%, 99%)
  • 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
Pleural Effusion: 91% (95% CI: 87%, 96%) , Consolidation/Atelectasis: 94% (95% CI: 90%, 98%)
  • 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.

Pleural-effusion detection sensitivity

97 percent

  • EndpointFinding detection sensitivity
  • PopulationLung ultrasound scans in the FDA bench dataset
  • Tested versionLung AI LAI001
Source

Pleural-effusion detection specificity

91 percent

  • EndpointFinding detection specificity
  • PopulationLung ultrasound scans in the FDA bench dataset
  • Tested versionLung AI LAI001
Source

Consolidation/atelectasis detection sensitivity

97 percent

  • EndpointFinding detection sensitivity
  • PopulationLung ultrasound scans in the FDA bench dataset
  • Tested versionLung AI LAI001
Source

Consolidation/atelectasis detection specificity

94 percent

  • EndpointFinding detection specificity
  • PopulationLung ultrasound scans in the FDA bench dataset
  • Tested versionLung AI LAI001
Source

K243239 FDA evidence package for Lung AI (LAI001)

  • DesignFDA 510(k) bench detection and localization validation.
  • Population465 lung-ultrasound scans from 359 unique patients at six U.S. and Canadian centers.
  • Scopeexact submission
  • Tested versionLung AI LAI001
  • Samplen=465
  • Sites6
  • IndependenceSponsor or vendor study

K243239

FDA-reported detection results for the exact LAI001 configuration; reader-aided results are not generalized here.

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

No public list price or commercial contract for the exact submission and version was identified.

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

No exact-product payer coverage or reimbursement determination was identified in reviewed public material.

No product-specific code

No exact-product reimbursement determination identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.

Source

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
No record matched K243239 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

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
2026-09-04Last searched
27Fields reviewed
11Source classes checked
6Screened PubMed leads
3Screened trial leads
0Unreviewed FDA recall leads

No evidence was promoted. All records concern unrelated cancer, CT, animal, or lung-ultrasound products from other vendors and do not identify Exo Lung AI LAI001 or K243239. The current discovery snapshot contains 6 PubMed and 3 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 decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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) decision material K243239: Lung AI (LAI001)

    U.S. Food and Drug Administration - Published 2025-04-24 - Accessed 2026-09-04

    Scope: identity, submission_linkage, modality, anatomy, clinical_use, intended_users, care_setting, workflow_role, input, output, limitations, evidence

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Lung AI (LAI001) model card (K243239)

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

    Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies

  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. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K243239 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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