BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P030007 · Supplement: S003 · Decision Mar 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    KODAK MAMMOGRAPHY CAD ENGINE
    PMA Number
    P030007
    Supplement Number
    S003
    Device Class
    FDA Class 2
    Product Code
    MYN
    Generic Name
    Analyzer, medical image
    Regulation Number
    892.2070
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 23, 2007
    Date Received
    February 28, 2007
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT EASTMAN KODAK COMPANY, ROCHESTER, NEW YORK. THIS IS ASOFTWARE MANUFACTURING LOCATION CHANGE THAT CONSISTS OF A SERVER MOVE FROM SAN JOSE, CALIFORNIA TO ROCHESTER, NEW YORK.

    Classifications

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

    Product Code Device Name
    MYN Analyzer, Medical Image