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    K Number
    K242919
    Device Name
    V5med Lung AI
    Manufacturer
    V5med Inc.
    Date Cleared
    2025-03-27

    (184 days)

    Product Code
    OEB, LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    V5med Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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. This software provides adjunctive information to alert radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. It can be used in a concurrent read mode, where the AI analysis results are displayed alongside the original CT images during either the initial review or any subsequent reviews by the radiologist. V5med Lung AI does not replace the radiologist's critical judgment or diagnostic processes and should not be used in isolation from the original CT series.
    Device Description
    The V5med Lung AI is a software product designed to detect nodules in the lungs. 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. The system integrates algorithm logic and database on the same server, ensuring simplicity and ease of maintenance. It accepts chest CT images from a PACS system, Radiological Information System (RIS), or directly from a CT scanner, analyzes the images, and provides output annotations regarding lung nodules.
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