Radiology AI Directory

FDA-cleared profile

LungQ Software

Thirona Corporation

Authorized purpose: Provide quantitative support for physician diagnosis, follow-up examination, and documentation of pulmonary-tissue images or abnormalities from CT thoracic datasets.

Quantification and segmentation
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

Authorized purpose: Provide quantitative support for physician diagnosis, follow-up examination, and documentation of pulmonary-tissue images or abnormalities from CT thoracic datasets.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Provide quantitative support for physician diagnosis, follow-up examination, and documentation of pulmonary-tissue images or abnormalities from CT thoracic datasets.

Evidence takeaway

Evidence from the reviewed source record: FDA K173821 compared LungQ 1.1.0 with VIDA PW2 on 250 randomly selected COPDGene CT scans spanning subjects with and without COPD and multiple disease stages. Lung/lobar volume and density outputs were assessed against prespecified equivalence limits. A separate fissure study used 55 scans from a five-site multicenter study in Germany, the Netherlands, and Sweden and compared voxel-wise fissure completeness with a manual reference; mean Az was 0.95 for LungQ 1.1.0 versus 0.76 for the previously published version (p<0.001). Az is an AUC endpoint, not sensitivity or specificity.

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
Provide quantitative support for physician diagnosis, follow-up examination, and documentation of pulmonary-tissue images or abnormalities from CT thoracic datasets.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Physicians; the FDA packet does not further specify user credentials.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Clinical CT pulmonary interpretation and follow-up workflow; the FDA packet does not specify a facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Command-line post-processing and quantitative-analysis aid; it supplies segmentation, volume/density/fissure measurements, and reports and has no graphical user interface.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DICOM CT thoracic datasets that may contain pulmonary abnormalities.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Three-dimensional segmentation and isolation of the left and right lungs and lobes; lung/lobar volume, density-range and 15th-percentile measurements; fissure evaluation; and a report.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The software is command-line and has no graphical user interface; the comparison table states that users cannot manually edit the segmentation. The reported equivalence criteria were volume difference <=10%, LAA-950HU agreement limits -1% to 1%, LAA-910HU limits -10% to 10%, and 15th-percentile limits -10 HU to 10 HU. The packet does not establish a disease-classification sensitivity or specificity endpoint.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K173821
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Thorax and lungs, including left and right lungs, lobes, pulmonary tissue, and fissures.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2018-06-05
  • 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
DICOM loading and command-line/Image Analysis Service processing are described; the packet does not name a PACS, RIS, EHR, routing interface, or current deployment topology.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for LungQ Software; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
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
FDA K173821 compared LungQ 1.1.0 with VIDA PW2 on 250 randomly selected COPDGene CT scans spanning subjects with and without COPD and multiple disease stages. Lung/lobar volume and density outputs were assessed against prespecified equivalence limits. A separate fissure study used 55 scans from a five-site multicenter study in Germany, the Netherlands, and Sweden and compared voxel-wise fissure completeness with a manual reference; mean Az was 0.95 for LungQ 1.1.0 versus 0.76 for the previously published version (p<0.001). Az is an AUC endpoint, not sensitivity or specificity.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

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

LungQ regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K173821
  • Samplen=250
  • IndependenceIndependence not established

K173821

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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 2026-09-09

No public price or quote for the exact K173821 configuration was established in this review.

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

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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
The exact-identifier FDA recall query returned no native recall record for K173821. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

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
2026-09-20Last searched
23Fields reviewed
9Source classes checked
7Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 7 PubMed and 0 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 7 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, fda device recall, 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 K173821: LungQ Software

    U.S. Food and Drug Administration - Published 2018-06-05 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. LungQ model card (K173821)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, output, limitations, evidenceSummary, 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. openFDA exact recall query for K173821

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

    Scope: postmarketSafety

Research history

  1. K173821 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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