FDA-cleared profile
Exo Inc
Authorized purpose: Exo AI Platform AIP001 processes imported adult ultrasound DICOM images for lung A-line and B-line assessment and cardiac ejection-fraction measurement and reporting.
Product overview
Authorized purpose: Exo AI Platform AIP001 processes imported adult ultrasound DICOM images for lung A-line and B-line assessment and cardiac ejection-fraction measurement and reporting.
Overview status: Source-reviewed overview
Clinical role: Exo AI Platform AIP001 processes imported adult ultrasound DICOM images for lung A-line and B-line assessment and cardiac ejection-fraction measurement and reporting.
Evidence from the reviewed source record: K232501 reports independent test data from diverse sites and demographics: 125 lung subjects and 151 LVEF subjects. Overall LVEF ICC was 0.93 with RMSD 5.90; A-line kappa was 0.84 and B-line-count ICC was 0.97.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The packet names qualified users and trained healthcare providers, not the dossier's more specific professional role class.
The packet directly states imported DICOM ultrasound images and does not state release-specific user inputs.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
This is the packet's direct use limitation; the dossier's source-image review requirement is not stated.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The packet's anatomical-sites table states Heart and Lungs; it does not use the dossier's Chest/Heart wording. Controlled directory display reconciled from exact FDA wording: Heart, Lungs. -> Chest/Heart.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K232501 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
DICOM import and output to PACS, reporting, or downstream systems; validate identifiers, series selection, measurements, units, geometry, routing, and round trips.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Outputs supplement accepted interpretation methods and require review against source images; supported modality, anatomy, protocol, and version limits apply.
exact submission · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track these product-specific limits: Outputs supplement accepted interpretation methods and require review against source images; supported modality, anatomy, protocol, and version limits apply.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
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.
Sensitivity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
Specificity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
0.93 ICC
5.9 RMSD
0.84 Cohen kappa
0.97 ICC
K232501
Manufacturer evidence submitted for clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 20 PubMed and 10 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, vendor product page, reimbursement policy, fda device recall, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, modality, output, evidenceSummary, anatomy, intendedUsers, input, limitations, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: integration, deployment, monitoring, productFamilyContext
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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