RevealAI-Lung Software is a computer aided diagnostic (CADx) software application intended for the characterization of incidentally-detected lung nodules on computed tomography (CT) scans. When a nodule is identified, the Software automatically compares the nodule characteristics with a clinically established database of lung nodules and provides a similarity score to assist clinicians' assessment of patients' cancer risk. The mSI score is indicated for the evaluation of incidentally-detected pulmonary nodules of diameter 6-15mm in patients aged 18 years or above. In cases where multiple abnormalities are present, the mSI score can be used to assess each abnormality independently. Risk should be interpreted on an individual patient level and mSI is a relative risk score, not a percentage cancer risk. Note that mSI is not indicated for lung cancer screening. The validation data excluded CT images with missing slices.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
RevealAI-Lung Software is a computer aided diagnostic (CADx) software application intended for the characterization of incidentally-detected lung nodules on computed tomography (CT) scans. When a nodule is identified, the Software automatically compares the nodule characteristics with a clinically established database of lung nodules and provides a similarity score to assist clinicians' assessment of patients' cancer risk. The mSI score is indicated for the evaluation of incidentally-detected pulmonary nodules of diameter 6-15mm in patients aged 18 years or above. In cases where multiple abnormalities are present, the mSI score can be used to assess each abnormality independently. Risk should be interpreted on an individual patient level and mSI is a relative risk score, not a percentage cancer risk. Note that mSI is not indicated for lung cancer screening. The validation data excluded CT images with missing slices.
Public source Exact FDA submission Checked 2026-09-01
Exact-submission indication text from the ACR AI Central model card. FDA labeling remains controlling.
CT images or data. Inclusion criteria: Incidentally-detected pulmonary nodules of diameter 6-15mm on CT scans in patients aged 18 years or above; solid and/or semi-solid and pure ground glass opacity nodules; contrast-enhanced and non-contrast CT scans; CT images acquired at slice spacing not exceeding 5mm
Public source Exact FDA submission Checked 2026-09-01
Conservative normalization of explicit wording in an exact-submission source.
The software provides a malignancy similarity index (mSI) score for each user-selected nodule, expressed as a numeric value from 0 to 1 (0 = lowest malignancy risk, 1 = highest malignancy risk). The score is displayed with a histogram showing the distribution of benign vs. malignant cases from the NLST training database at each score level, to provide contextual reference for the radiologist in assessing cancer risk of incidentally-detected pulmonary nodules.
Public source Exact FDA submission Checked 2026-09-01
Clinical output reported in the exact-submission ACR model card.
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
K251769
FDA source Exact FDA submission Checked 2026-08-31
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.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
Study type: Both. Cases: 675. Reference standard: Interpretation by Reviewing Clinician. Reader-study cases: 108. Reader-study sensitivity: 82%. Reader-study specificity: 46.7%
Public source Exact FDA submission Checked 2026-09-01
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
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.
RevealAI-Lung regulatory performance study summary
Stand-alone performance and reader study (ACR AI Central category) · Adult
exact submission · Tested version: Exact product version not reported; regulatory study summarized for FDA submission K251769 · n=675 · Independence not established
K251769
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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.
Verify deployment and data flow: Attach an exact-product deployment and data-flow source.
Verify security and privacy controls: 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.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Verify recalls and postmarket safety signals: 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.
This audit distinguishes completed source review from fields that have not yet been researched.
Automated sources checkedStatus
2026-09-04Last searched
15Fields reviewed
5Source classes checked
2Unreviewed PubMed leads
0Unreviewed 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. Automated exact-name discovery found 2 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, acr ai central product, pubmed, clinical trials, openfda device recall
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