BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Imaging, Fluorescence

    PMA: P950042 · Supplement: S001 · Decision Jul 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Imaging, Fluorescence
    Trade Name
    XILLIX-LIFE-LUNG
    PMA Number
    P950042
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    MRK
    Generic Name
    SYSTEM, IMAGING, FLUORESCENCE
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 21, 1998
    Date Received
    April 30, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval to amend the post-market study. A third investigator will be added to assist in collecting sets of images whichwill be used to produce the "test set" of images for the reproducibility testing.

    Classifications

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

    Product Code Device Name
    MRK System, Imaging, Fluorescence