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

    Interlocked Circular Small Field Collimators, Elekta Integrated

    K Number: K161984 · Decision Sep 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    124
    Same Product Code
    717
    Applicant Total
    2
    Review Days
    70

    Basic Information

    Device Name
    Interlocked Circular Small Field Collimators, Elekta Integrated
    K Number
    K161984
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AKTINA MEDICAL CORPORATION
    Date Received
    July 19, 2016
    Decision Date
    September 27, 2016
    Product Code
    IYE
    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
    IYE Accelerator, Linear, Medical

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