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V5med Lung AI

by V5med, Inc. 510(k)

Active United States

510(k) K242919

Overview

V5med Lung AI is a Lung Computed Tomography System with Computer-Aided Detection functionality. It is designed to support the detection and quantification of lung nodules, emphysema, pulmonary fibrosis, and coronary artery calcification from low-dose CT imaging.

The device is supplied as software and is intended for use in radiology settings. It has received FDA 510(k) clearance under product code OEB and regulation number 892.2050, with clearance granted on March 27, 2025, under K242919.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242919 Date27 Mar 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
OEB
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is V5med Lung AI used for?

    V5med Lung AI is designed to support the detection and quantification of lung nodules, emphysema, pulmonary fibrosis, and coronary artery calcification from low-dose CT imaging. It functions as a Lung Computed Tomography System with Computer-Aided Detection functionality, intended for use in radiology settings to assist clinicians in analyzing CT scans for these specific pulmonary and cardiovascular conditions.

  • How is V5med Lung AI supplied and what type of device is it?

    V5med Lung AI is supplied as software only and is intended for use in radiology settings. It is classified as a Lung Computed Tomography System with Computer-Aided Detection functionality, meaning it operates as a digital tool that processes low-dose CT images to aid in the identification and measurement of lung-related abnormalities, without any hardware components included in its supply.

  • Is V5med Lung AI a single-use or reusable device?

    V5med Lung AI is software and therefore does not involve physical use that would classify it as single-use or reusable in the traditional sense. As a software application, it can be installed and used repeatedly on compatible systems within a radiology environment, with no physical degradation or contamination risk from use, making it effectively reusable for ongoing clinical support.