BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODEL ESP-200 MAMMOGRAPHIC SYSTEM

    K Number: K884345 · Decision Mar 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    13
    Review Days
    160

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    Basic Information

    Device Name
    MODEL ESP-200 MAMMOGRAPHIC SYSTEM
    K Number
    K884345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Acoma Medical Imaging, Inc.
    Date Received
    October 14, 1988
    Decision Date
    March 23, 1989
    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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