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

    Encompass SRS Headframe ; Encompass MR SRS Headframe

    K Number: K182189 · Decision Oct 4, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    7
    Review Days
    52

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    Basic Information

    Device Name
    Encompass SRS Headframe ; Encompass MR SRS Headframe
    K Number
    K182189
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qfix
    Date Received
    August 13, 2018
    Decision Date
    October 4, 2018
    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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