Radiology AI Directory

FDA-cleared profile

qCT LN Quant

Qure.ai Technologies

Quantitative characterization and longitudinal tracking of user-detected solid pulmonary nodules at least 6 mm on chest CT.

Lung nodule detectionDetection and CADeQuantification 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.

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 characterization and longitudinal tracking of user-detected solid pulmonary nodules at least 6 mm on chest CT.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Radiologists and pulmonologists; certified medical specialists trained and experienced in reviewing and reporting chest CT.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Chest CT and radiology workflow for single or serial thoracic studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
User-assisted semi-automatic nodule segmentation, measurement, and longitudinal comparison; results are informational, not diagnostic, and the clinician reviews and corrects the segmentation against the original images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Non-contrast chest CT scans with user-selected or user-segmented solid pulmonary nodules at least 6 mm; DICOM input, received as de-identified scans through a modality or PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Quantitative nodule average, long-axis, short-axis, and effective diameters, volume, mean/minimum/maximum HU, volume-doubling time, 2D/3D segmented views, Lung-RADS calculation, Brock Score risk calculation, and Fleischner-guideline-based reporting support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The device is not intended to diagnose disease or replace physician evaluation. Image noise and artifacts may reduce performance; use is not intended for idiopathic pulmonary fibrosis or extensive granulomatous disease or scans outside compatibility. Follow-up should use consistent CT parameters, and the clinician must verify or manually correct segmentation. Calculator and guideline outputs depend on user-entered information.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K240740
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Chest and lungs
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-08-16
  • 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
A cloud module receives de-identified DICOM scans from a modality or PACS and returns results to the same destination. PACS mode uses a secondary-capture series with segmentation for PACS supporting GSPS output; web mode displays overlays in the Qure web application. Exact local interfaces and versions are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-cloud
  • 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 2026-09-08

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 2026-09-08

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 2026-09-08

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

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

ACR exact-submission catalog context

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

exact submission · checked 2026-09-08
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 standalone clinical performance testing included 216 solid nodules from 118 chest CT scans of 104 subjects, with ground truth established by three expert radiologists. Median absolute normalized errors were 14.3% for short-axis diameter (95% CI 13.95%-16.67%), 11.1% for long-axis diameter (9.52%-12.50%), and 20.7% for volume (17.29%-22.41%). The packet describes these as quantitative measurement results against the reference standard and does not report diagnostic sensitivity or specificity.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
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.

qCT LN Quant 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 K240740
  • Samplen=104
  • IndependenceIndependence not established

K240740

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 2026-09-08

No public price or quote for the exact K240740 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K240740. 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 2026-09-08

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
2026-09-08Last searched
21Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting 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. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 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, 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 K240740: qCT LN Quant

    U.S. Food and Drug Administration - Published 2024-08-16 - Accessed 2026-09-08

    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. qCT LN Quant model card (K240740)

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

    Scope: intendedUsers, 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. openFDA exact recall query for K240740

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K240740 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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