FDA-cleared profile
V5med Inc.
Authorized purpose: V5med Lung AI provides concurrent-read adjunctive notification of suspected pulmonary nodules on chest CT; it does not replace radiologist judgment, diagnostic processes, or review of original CT series.
Product overview
Authorized purpose: V5med Lung AI provides concurrent-read adjunctive notification of suspected pulmonary nodules on chest CT; it does not replace radiologist judgment, diagnostic processes, or review of original CT series.
Overview status: Source-reviewed overview
Clinical role: V5med Lung AI provides concurrent-read adjunctive notification of suspected pulmonary nodules on chest CT; it does not replace radiologist judgment, diagnostic processes, or review of original CT series.
Evidence from the reviewed source record: A retrospective fully crossed multi-reader, multi-case study used 340 chest CT cases reviewed by 16 board-certified radiologists; screening and nonscreening CT were included.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Specific interface versions and site compatibility require confirmation.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
No dated, scoped security documentation was reviewed.
Current training/support commitments were not established.
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
The vendor describes serial-nodule comparison, volume-doubling-time and report-support functions.
product family ยท checked 2026-09-05These current product-family claims are not evidence that every function was in the K242919 configuration.
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.
No complete numerical sensitivity endpoint was abstracted.
No complete numerical specificity endpoint was abstracted.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K242919
The FDA summary describes LROC/AUC comparison with and without AI; no numerical endpoints were carried forward without complete extracted context.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No scoped public price or procurement award was reviewed.
No applicable payer policy was reviewed.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
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.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Stored trial metadata was screened. NCT06514248 is a V5-LU01 thoracic CT record; the direct registry page was not readable and exact configuration/protocol linkage was not established, so no study result was promoted. No stored PubMed candidates. The current discovery snapshot contains 0 PubMed and 1 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 decision material, vendor product page, literature index, trial registry, fda device recall, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: identity, clinicalUse, modality, anatomy, input, output, limitations, integration, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: intendedUsers, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamilyWorkflow, implementationCapabilities
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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