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510(k) Data Aggregation

    K Number
    K091999
    Device Name
    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
    Manufacturer
    ACCURAY, INC.
    Date Cleared
    2009-09-18

    (78 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCURAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CyberKnife VSI™ Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.
    Device Description
    The CyberKnife VSI Robotic Radiosurgery System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife VSI uses skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.
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    K Number
    K091146
    Device Name
    MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
    Manufacturer
    ACCURAY, INC.
    Date Cleared
    2009-05-01

    (11 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCURAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CyberKnife® Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.
    Device Description
    The CyberKnife Robotic Radiosurgery System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking, fiducial tracking, Xsight™ Spine Tracking, Xsight" Lung Tracking, and Synchrony" Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.
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    K Number
    K062967
    Device Name
    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
    Manufacturer
    ACCURAY, INC.
    Date Cleared
    2006-10-30

    (31 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCURAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CyberKnife® Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated. The CyberKnife® Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    Device Description
    The CyberKnife Robotic Radiosurgery System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking, fiducial tracking, Xsight™ spine tracking, Synchrony" Respiratory Tracking and Lung Tumor Tracking for dynamic positioning and pointing of the linear accelerator.
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    K Number
    K051941
    Device Name
    CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
    Manufacturer
    ACCURAY, INC.
    Date Cleared
    2005-08-09

    (22 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCURAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CyberKnife System for Stereotactic Radiosurgery/Radiotherapy is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, turnors and conditions anywhere in the body when radiation treatment is indicated.
    Device Description
    The CyberKnife System is a computer-controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target anywhere in the body.
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    K Number
    K041315
    Device Name
    CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
    Manufacturer
    ACCURAY, INC.
    Date Cleared
    2004-06-10

    (24 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCURAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CyberKnife System for Stereotactic Radiosurgery/Radiotherapy is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    Device Description
    The CyberKnife System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking, fiducial tracking and skeletal structure tracking for dynamic positioning and pointing of the linear accelerator.
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    K Number
    K032345
    Device Name
    CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
    Manufacturer
    ACCURAY, INC.
    Date Cleared
    2003-09-03

    (35 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCURAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CyberKnife System for Stereotactic Radiosurgery/Radiotherapy is intended to provide treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    Device Description
    The CyberKnife System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a sophisticated target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking and tracking of implanted fiducials for dynamic positioning and pointing of the linear accelerator.
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    K Number
    K020294
    Device Name
    MOTION TRACKING
    Manufacturer
    ACCURAY, INC.
    Date Cleared
    2002-04-22

    (84 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCURAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide an option to the CyberKnife System which will enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.
    Device Description
    Presently, irradiation of lesions that move during breathing, such as those located in the lung or near the diaphragm, would typically be performed during patient breath-holds. The Motion Tracking System option to the CyberKnife® System is designed to treat lesions while they are moving during the respiratory cycle. This offers the ability to reduce normal tissue exposure by using smaller irradiation margins, shorten treatments, increase accuracy and provide more comfort for the patient. During motion tracking operation, a correspondence between surface (e.g. thorax/abdomen) movements and movement of the target lesion is developed prior to the start of treatment and is regularly updated during treatment each time the CyberKnife system acquires a new pair of x-ray images. This correspondence is then used to estimate lesion position in real time by monitoring surface movement during treatment. Motion Tracking provides the CyberKnife system with the capability to monitor the patient's respiration and command the robot manipulator to compensate for the treatment target motion within the body, in real-time, while the radiation is being delivered. The Motion Tracking System includes a sensor assembly, tracking targets, a cable junction box, and a controller.
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    K Number
    K011024
    Device Name
    CYBERKNIFE SYSTEM
    Manufacturer
    ACCURAY, INC.
    Date Cleared
    2001-08-10

    (128 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCURAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000478
    Device Name
    THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
    Manufacturer
    ACCURAY, INC.
    Date Cleared
    2000-04-19

    (65 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCURAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K984563
    Device Name
    THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
    Manufacturer
    ACCURAY, INC.
    Date Cleared
    1999-07-14

    (203 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCURAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS), cervico-thoracic spine (CTS), head and neck.
    Device Description
    The CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy is a treatment planning, imaging, and treatment delivery system for image-guided stereotactic radiosurgery and precision radiotherapy. The treatment planning system provides 3-dimensional viewing of the patient anatomy with appropriate dose calculation of the target volume and surrounding tissue structures. The imaging system provides real-time, orthogonal x-ray images of the patient in the treatment position to verify treatment position and accuracy and provides information suitable for dynamically positioning and pointing a linear accelerator. The treatment delivery system consists of a linear accelerator which provides 6 MV x-rays. A six-access manipulator provides automated positioning and pointing of the linear accelerator. The treatment couch provides positioning of the patient.
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