Radiology AI Directory

FDA-cleared profile

LungQ 4

Thirona BV

Quantitative support for thoracic CT interpretation and treatment planning, including emphysema burden, airway/lung segmentation, endobronchial valve assessment and estimated chronic perfusion defect.

Quantification 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.

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
Quantitative support for thoracic CT interpretation and treatment planning, including emphysema burden, airway/lung segmentation, endobronchial valve assessment and estimated chronic perfusion defect.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Intended users
Radiologists, pulmonologists and other qualified healthcare professionals interpreting thoracic CT.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Care setting and population
Pulmonary and radiology services using thoracic CT, including evaluation for emphysema and endobronchial valve treatment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Workflow role
Quantitative analysis and treatment-planning aid used with thoracic CT; clinicians review the source images and results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Required input
DICOM thoracic CT datasets processed by a Docker image and standalone command-line application; the cleared configuration has no graphical user interface.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Output and human action
3D left/right lung, lobe, subsegment and airway segmentations; lung volume; density distributions and 15th-percentile density; LAA-950HU and LAA-910HU scores; fissure analysis; specified endobronchial implant count/analysis; and estimated chronic perfusion defect.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Limitations
The application is an adjunctive quantitative tool and does not replace clinician review. The public summary describes a command-line, no-GUI deployment, and local operators must verify input routing, supported CT protocols and interpretation workflow.
  • 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
K250766
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • 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
2025-10-02
  • 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
Receives DICOM thoracic CT datasets and returns derived analyses for use with the source study; the cleared submission does not establish a buyer's specific PACS, orchestration or reporting configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Deployment and data flow
Docker image and standalone command-line software without a GUI.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

Docker packaging does not establish the customer's security controls, data 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.

Containerized command-line deployment

The cleared software is distributed as a Docker image and standalone command-line application without a GUI.

exact submission · checked 2026-09-07
Source

Versioned implementation documentation

Thirona maintains an official manuals and configuration-files portal for LungQ products; the landing page does not establish the exact K250766 package, support contract or local integration terms.

product family · checked 2026-09-07
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 summary reports head-to-head agreement with LungQ v3 for volume, density and airway segmentation. In the endobronchial implant dataset, valve sensitivity was at least 95% and precision at least 90%. Chronic perfusion-defect analysis met prespecified agreement criteria against perfusion reference methods; no sample size was stated in the reviewed summary.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Reported sensitivity
>=95% for endobronchial valve detection in the FDA-described validation dataset
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

This endpoint is specific to the described endobronchial implant dataset, not a general thoracic CT sensitivity claim.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-07

The FDA summary reports precision for endobronchial valve detection, not a general exact-submission specificity endpoint.

Endobronchial valve detection sensitivity

0.95 proportion, minimum reported threshold

  • EndpointSensitivity
  • PopulationEndobronchial implant CT dataset with expert clinical truthers
  • Tested versionLungQ 4 configuration submitted in K250766
Source

Endobronchial valve detection precision

0.9 proportion, minimum reported threshold

  • EndpointPrecision
  • PopulationEndobronchial implant CT dataset with expert clinical truthers
  • Tested versionLungQ 4 configuration submitted in K250766
Source

LungQ 4 quantitative segmentation validation

  • DesignHead-to-head software validation against LungQ v3 described in the FDA 510(k) summary
  • PopulationThoracic CT datasets for lung, lobe, airway volume, density and segmentation analyses
  • Scopeexact submission
  • Tested versionLungQ 4 configuration submitted in K250766
  • IndependenceSponsor or vendor study

K250766

Acceptance criteria were met for the described analyses; the public summary does not provide one consolidated cohort size.

Source

LungQ 4 endobronchial implant analysis validation

  • DesignMulticenter CT dataset with post-treatment studies and negative controls, interpreted against expert clinical truthers
  • PopulationPatients with endobronchial implants and negative controls
  • Scopeexact submission
  • Tested versionLungQ 4 configuration submitted in K250766
  • IndependenceSponsor or vendor study

K250766

FDA reports valve sensitivity >=95% and precision >=90%.

Source

LungQ 4 chronic perfusion-defect analysis validation

  • DesignComparison with HRCT plus planar perfusion scintigraphy and HRCT plus SPECT-CT; pulmonologist treatment-planning assessment
  • PopulationThoracic CT cases evaluated against perfusion reference methods
  • Scopeexact submission
  • Tested versionLungQ 4 configuration submitted in K250766
  • IndependenceSponsor or vendor study

K250766

FDA reports ICC >0.75, bias <5% and limits of agreement from -10% to 10%; cohort size was not stated in the reviewed summary.

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 the K250766 configuration 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
22Fields reviewed
11Source 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 press release, vendor documentation portal, 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) K250766: LungQ 4

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

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

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. LungQ 4 model card (K250766)

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

    Scope: intendedUsers, careSetting, output, 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. Thirona Receives FDA Clearance for LungQ 4 Software

    Thirona - Accessed 2026-09-06

    Scope: productFamilyContext, clinicalUse, implementationCapabilities

  8. Download Manuals & Configuration Files

    Thirona - Accessed 2026-09-07

    Scope: implementationCapabilities

Research history

  1. K250766 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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