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 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
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.
FDA source Exact FDA submission Checked 2026-09-05
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
K242919
FDA source Exact FDA submission Checked 2026-08-31
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.
Vendor confirmation Exact FDA submission Checked 2026-09-06
No dated, scoped security documentation was reviewed.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
Current training/support commitments were not established.
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.
Current product-family nodule workflow
The vendor describes serial-nodule comparison, volume-doubling-time and report-support functions.
product family · checked 2026-09-05
These current product-family claims are not evidence that every function was in the K242919 configuration.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
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.
FDA source Exact FDA submission Checked 2026-09-05
Reviewed sources checked Exact FDA submission Checked 2026-09-05
No complete numerical sensitivity endpoint was abstracted.
Reported specificity
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-05
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.
V5med Lung AI K242919 reader study
Retrospective fully crossed multi-reader, multi-case study · 340 screening and nonscreening chest CT cases; 16 board-certified radiologists
exact submission · Tested version: V5-LU01 submitted in K242919; build not stated · n=340 · Independence not established
K242919
The FDA summary describes LROC/AUC comparison with and without AI; no numerical endpoints were carried forward without complete extracted context.
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 2026-09-06
No scoped public price or procurement award was reviewed.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-06
No applicable payer policy was reviewed.
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.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: No dated, scoped security documentation was reviewed.
Verify training: Current training/support commitments were not established.
Verify pricing and total cost: No scoped public price or procurement award was reviewed.
Verify reimbursement and coding relevance: No applicable payer policy was reviewed.
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.
Human reviewedStatus
2026-09-05Last searched
22Fields reviewed
11Source classes checked
0Reviewed PubMed leads
1Reviewed trial leads
0Unreviewed FDA recall leads
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
eyonis LCS is a concurrent-reading aid for radiologists that detects, localizes, and characterizes 4-30 mm solid and part-solid pulmonary nodules on low-dose chest CT images for...
Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
BriefCase analyzes contrast-enhanced chest CT for suspected pulmonary embolism and notifies or prioritizes the study in the labeled hospital or cloud worklist workflow; the output...