Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
qCT LN Quant
Qure.ai Technologies
Authorized purpose: Quantitative characterization and longitudinal tracking of user-detected solid pulmonary nodules at least 6 mm on chest 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
Authorized purpose: Quantitative characterization and longitudinal tracking of user-detected solid pulmonary nodules at least 6 mm on chest CT.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Quantitative characterization and longitudinal tracking of user-detected solid pulmonary nodules at least 6 mm on chest CT.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Chest and lungs 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.
- Who uses it? Intended users: Radiologists and pulmonologists; certified medical specialists trained and experienced in reviewing and reporting chest CT.
- What does the software produce? Output: 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.
- What is its most important limitation? Key limitation: 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.
Clinical takeaway
Clinical role: Quantitative characterization and longitudinal tracking of user-detected solid pulmonary nodules at least 6 mm on chest CT.
Evidence takeaway
Evidence from the reviewed source record: 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.
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.
- Intended users
- Radiologists and pulmonologists; certified medical specialists trained and experienced in reviewing and reporting chest CT.
- Care setting and population
- Chest CT and radiology workflow for single or serial thoracic studies.
- 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.
- 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.
- 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.
- 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.
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.
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.
- Deployment and data flow
- On-cloud
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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 2026-09-08Evidence
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.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
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.
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
No public price or quote for the exact K240740 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K240740 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
22Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. 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, 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
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FDA K240740: qCT LN Quant
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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qCT LN Quant model card (K240740)
Scope: intendedUsers, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K240740
Scope: postmarketSafety
Research history
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K240740 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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