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

    Sensor, Electro-Optical (For Cervical Cancer)

    PMA: P040028 · Supplement: S001 · Decision Apr 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sensor, Electro-Optical (For Cervical Cancer)
    Trade Name
    LUMA CERVICAL IMAGING SYSTEM
    PMA Number
    P040028
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    MWM
    Generic Name
    Sensor, electro-optical (for cervical cancer)
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 11, 2006
    Date Received
    March 20, 2006
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATIONS TO THE INCOMING CAMERA INSPECTION TEST, TEST SOFTWARE USED TO ASSEMBLE THE LUMA SYSTEM AND THE FINAL TEST SOFTWARE USED DURING BURN-IN.

    Classifications

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

    Product Code Device Name
    MWM Sensor, Electro-Optical (For Cervical Cancer)