BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    IGUIDE SYSTEM

    K Number: K072079 · Decision Aug 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    3
    Review Days
    15

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    Basic Information

    Device Name
    IGUIDE SYSTEM
    K Number
    K072079
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Intelligence Medizintechnik-GmbH-An Elekta
    Date Received
    July 30, 2007
    Decision Date
    August 14, 2007
    Product Code
    IYE
    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
    IYE Accelerator, Linear, Medical

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    Other Clearances by Medical Intelligence Medizintechnik-GmbH-An Elekta

    K Number Device Name
    K062639 MODIFICATION TO HEXAPOD RT COUCH TOP
    K062611 IGUIDE SYSTEM