BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    MAMMOGRAPHY SYSTEM AND CASSETTE

    K Number: K790273 · Decision Mar 21, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    3
    Review Days
    41

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    Basic Information

    Device Name
    MAMMOGRAPHY SYSTEM AND CASSETTE
    K Number
    K790273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Agfa-Gevaert, Inc.
    Date Received
    February 8, 1979
    Decision Date
    March 21, 1979
    Product Code
    IZH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IZH System, X-Ray, Mammographic

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