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

    CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM

    K Number: K051941 · Decision Aug 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    255
    Applicant Total
    10
    Review Days
    22

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    Basic Information

    Device Name
    CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
    K Number
    K051941
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accuray, Inc.
    Date Received
    July 18, 2005
    Decision Date
    August 9, 2005
    Product Code
    MUJ
    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
    MUJ System, Planning, Radiation Therapy Treatment

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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
    K041315 CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
    K032345 CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
    K020294 MOTION TRACKING
    K011024 CYBERKNIFE SYSTEM
    K000478 THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
    K984563 THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY