V5med Lung AI

K242919

V5med Inc. · cleared 2025-03-27 · product code OEB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“V5med Lung AI is a Computer-Aided Detection (CAD) software designed to assist radiologists in detecting pulmonary nodules (with diameter of 4-30 mm) during CT examinations of the chest for asymptomatic populations.”

AlgorithmDeep Convolutional Neural Network (CNN) based algorithm

source quote (p.6)

“The detection model is trained using a Deep Convolutional Neural Network (CNN) based algorithm, enabling automatic detection of lung nodules ranging from 4 to 30 mm in chest CT images.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

standards: General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002), Guidance for the Content of Premarket Submissions for Device Software Functions. (June 14, 2023), IEC 62304:2006/Amd 1:2015 - Medical device software-software life cycle processes

Standalone

sample size not stated

endpoints: detection accuracy

Reader study (MRMC)

n=340 scans

endpoints: area under the curve (AUC) of the localization-specific receiver operating characteristic (LROC) response; Radiologist interpretation times

Reported performance (1 observation)

aurocas written: “auc”0.83

source quote (p.11)

“AUC 0.830”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).