BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Fluorescence Imaging For Breast Cancer Detection

    PMA: P230014 · Supplement: S001 · Decision May 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Fluorescence Imaging For Breast Cancer Detection
    Trade Name
    Lumicell Direct Visualization System (DVS)
    PMA Number
    P230014
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    SAW
    Generic Name
    Fluorescence imaging for breast cancer detection
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 29, 2024
    Date Received
    April 29, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    changes to the Lumicell Direct Visualization System (DVS), consisting of a supplier change for the mirrors and lenses of the device and the implementation of a manufacturing fixture at the finished device manufacturer to facilitate the gluing procedure for the device

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SAW Fluorescence Imaging For Breast Cancer Detection