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

    OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM

    K Number: K072392 · Decision Sep 25, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    781
    Review Days
    29

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    Basic Information

    Device Name
    OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
    K Number
    K072392
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions USA, Inc.
    Date Received
    August 27, 2007
    Decision Date
    September 25, 2007
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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