Radiology AI Directory

FDA-cleared profile

Median LCS (internal name) / eyonis LCS (trade name) (1.0)

Median Technologies

eyonis LCS is a concurrent-reading aid for radiologists that detects, localizes, and characterizes 4-30 mm solid and part-solid pulmonary nodules on low-dose chest CT images for high-risk lung cancer screening patients; it provides nodule measurements and malignancy scores and does not replace physician judgment.

Lung nodule detectionDetection and CADeQuantification and segmentationChest CT
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

eyonis LCS is a concurrent-reading aid for radiologists that detects, localizes, and characterizes 4-30 mm solid and part-solid pulmonary nodules on low-dose chest CT images for high-risk lung cancer screening patients; it provides nodule measurements and malignancy scores and does not replace physician judgment.

Overview status: Field-derived fact summary This section is assembled from the sourced field records below; it is not a source-reviewed editorial overview.

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
eyonis LCS is a concurrent-reading aid for radiologists that detects, localizes, and characterizes 4-30 mm solid and part-solid pulmonary nodules on low-dose chest CT images for high-risk lung cancer screening patients; it provides nodule measurements and malignancy scores and does not replace physician judgment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13
Intended users
Radiologists interpreting low-dose chest CT for high-risk lung cancer screening.
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13
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
Measurement or quantification
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
CT/CTA images or data involving Chest/Lung; consult the FDA labeling for exact protocol, series, and quality requirements.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Output and human action
Nodule detection, localization, characterization, measurements, and malignancy scores for radiologist review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13
Limitations
Does not replace physician judgment; intended for the stated 4-30 mm solid and part-solid nodule context and high-risk screening population.
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

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
K251474
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13
Anatomy
Chest/Lung
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-02-06
  • 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 exact-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.

Deployment and data flow
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Attach an exact-product deployment and data-flow source.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response 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.

Research-study input

Chest low-dose CT DICOM images

product family · checked 2026-09-01

Registry description; exact commercial ingestion and protocol requirements require current technical documentation.

SourceSource

Research-study output

A DICOM result report summarizing detected nodules, localization, characterization, and malignancy score per patient

product family · checked 2026-09-01

Registry description; output routing and viewer behavior require current commercial implementation documentation.

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
Two completed sponsor-registered retrospective studies describe Median LCS / eyonis LCS: RELIVE evaluated assisted versus unassisted reader accuracy in 480 high-risk lung-cancer screening cases, and REALITY evaluated standalone performance in 1,147 cases. The registry records identify the product family but not FDA submission K251474 or a software version.
  • Public source
  • Product family
  • Checked 2026-09-01

Registry records establish study design and enrollment, not peer-reviewed results or exact-version equivalence.

Reported sensitivity
84.50% (95% CI: 80.22%, 88.17%)
  • 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
80.25% (95% CI: 77.33%, 82.95%)
  • 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.

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

RELIVE: retrospective multi-reader, multi-case assisted-reading study

  • DesignCompleted retrospective observational cohort and controlled multi-reader, multi-case comparison
  • Population480 high-risk lung-cancer screening cases evaluated for pulmonary-nodule detection, localization, and characterization
  • Scopeproduct family
  • Tested versionMedian LCS / eyonis LCS; registry does not identify the FDA submission or software version
  • Samplen=480
  • IndependenceSponsor or vendor study

NCT06751576

Sponsor: Median Technologies. Primary endpoint compares reader patient-level AUROC with and without device assistance.

Source

REALITY: multinational, multicenter retrospective standalone study

  • DesignCompleted multinational, multicenter retrospective observational cohort
  • Population1,147 high-risk lung-cancer screening cases with chest low-dose CT
  • Scopeproduct family
  • Tested versionMedian LCS / eyonis LCS; registry does not identify the FDA submission or software version
  • Samplen=1147
  • IndependenceSponsor or vendor study

NCT06576232

Sponsor: Median Technologies. Primary endpoint is patient-level AUROC, with sensitivity, specificity, PPV, and NPV identified as supporting measures.

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 2026-08-13

FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.

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
2026-09-04Last searched
19Fields reviewed
5Source classes checked
0Awaiting review PubMed leads
2Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. ClinicalTrials.gov candidate records were manually matched to the Median LCS / eyonis LCS product family; exact K251474 version equivalence was not established. Automated exact-name discovery found 0 PubMed and 2 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, acr ai central product, clinical trials, pubmed, 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. K251474 FDA 510(k) decision summary

    U.S. Food and Drug Administration - Accessed 2026-08-13

    Scope: purpose, modality, anatomy, output, limitations

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. eyonis® LCS 1.1 model card (K251474)

    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. RELIVE: reader study of Median LCS / eyonis LCS

    ClinicalTrials.gov - Accessed 2026-09-01

    Scope: evidenceStudy, population, input, output

  8. REALITY: standalone study of Median LCS / eyonis LCS

    ClinicalTrials.gov - Accessed 2026-09-01

    Scope: evidenceStudy, population, input, output

Research history

  1. K251474 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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