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

    THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1

    K Number: K000478 · Decision Apr 19, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    47
    Applicant Total
    10
    Review Days
    65

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    Basic Information

    Device Name
    THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
    K Number
    K000478
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accuray, Inc.
    Date Received
    February 14, 2000
    Decision Date
    April 19, 2000
    Product Code
    IWB
    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
    IWB System, Radiation Therapy, Radionuclide

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    Other Clearances by Accuray, Inc.

    K Number Device Name
    K091999 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
    K091146 MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
    K062967 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
    K051941 CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
    K041315 CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
    K032345 CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
    K020294 MOTION TRACKING
    K011024 CYBERKNIFE SYSTEM
    K984563 THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY