BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    MAMMI

    K Number: K140996 · Decision Jun 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    3
    Review Days
    55

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    Basic Information

    Device Name
    MAMMI
    K Number
    K140996
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    General Equipment For Medical Imaging (Oncovision-
    Date Received
    April 17, 2014
    Decision Date
    June 11, 2014
    Product Code
    KPS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    KPS System, Tomography, Computed, Emission

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    Other Clearances by General Equipment For Medical Imaging (Oncovision-

    K Number Device Name
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