Radiology AI Directory

FDA-cleared profile

RevealAI-Lung

Precision Medical Ventures, Inc. Dba Revealdx

Characterization and relative cancer-risk assessment of incidentally detected pulmonary nodules 6-15 mm in adults, with use as one input to follow-up and clinical decision-making under published guidelines; not lung-cancer screening

Lung nodule detectionDetection and CADe
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
Characterization and relative cancer-risk assessment of incidentally detected pulmonary nodules 6-15 mm in adults, with use as one input to follow-up and clinical decision-making under published guidelines; not lung-cancer screening
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Radiologists; the packet states RevealAI-Lung is intended only for radiologists and requires practitioner review
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Hospitals and healthcare provider office settings
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
User-selected CADx adjunct during routine lung CT interpretation: the radiologist identifies the nodule, opens an integrated MIMPS frame, and considers mSI with other risk factors and guidelines
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM CT image plus a spatial coordinate centered on a user-selected lung nodule; incidentally detected 6-15 mm pulmonary nodule in a patient aged 18 years or above; validation excluded CT images with missing slices
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Malignancy similarity index (mSI) from 0 to 1 for each selected nodule, plus a histogram relating the score to benign and malignant NLST reference cases; mSI is a relative risk score and not a percentage cancer risk
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not indicated for lung-cancer screening, modalities other than lung CT, non-lung-nodule locations, or unassisted reads; intended indication is adult incidentally detected nodules 6-15 mm; missing CT slices were excluded from validation
  • 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
K251769
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Pulmonary nodules in the 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
2026-01-30
  • 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
Imports DICOM from connected third-party devices, interfaces with an established MIMPS system, and displays analytics in an integrated frame; the packet says it does not display DICOM images and does not provide reporting-archive connectivity. Specific PACS/RIS interfaces and versions are not established
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

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.

ACR exact-submission catalog context

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

exact submission ยท 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 packet reports validation on 675 patients, including 276 with cancer, across additional US, Canadian, and UK populations. The MRMC study used 108 cases and 10 radiologists with a 28-day washout. Primary endpoint was reader AUC: mean 0.538 unaided versus 0.719 aided, delta 0.181, p<0.0001. At a prespecified 5% malignancy-likelihood threshold, reader sensitivity changed from 0.68 to 0.82 and specificity from 0.344 to 0.467; the packet cautions these are sample-dependent and not population statistics
  • 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.

RevealAI-Lung regulatory performance study summary

  • DesignStand-alone performance and reader study (ACR AI Central category)
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K251769
  • Samplen=675
  • IndependenceIndependence not established

K251769

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 K251769 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 K251769. 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
20Fields reviewed
9Source classes checked
2Awaiting 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 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, fda decision summary, 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 K251769: RevealAI-Lung

    U.S. Food and Drug Administration - Published 2026-01-30 - 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. RevealAI-Lung model card (K251769)

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

    Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, anatomy, evidenceStudies

  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 K251769

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

    Scope: postmarketSafety

Research history

  1. K251769 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

Alternatives

Related tools to compare

FDA-cleared K254075

Synapse Lung Nodule AI

Fujifilm Corporation

Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.

Modality
CT/CTA
Anatomy
Chest/lungs; pulmonary nodules
Decision
2026-05-27
Lung nodule detectionDetection and CADe