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510(k) Data Aggregation

    K Number
    K170788
    Device Name
    CyberKnife Treatment Delivery System
    Date Cleared
    2017-04-11

    (26 days)

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

    Accuray Incorportaed

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CyberKnife® Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The CyberKnife® Treatment Delivery System may be used to treat astrocytoma, glioma, skull base tumors, metastases (brain and bony), nasopharyngeal carcinoma, meningioma, acoustic neuroma, schwannoma, pituitary adenoma, hemangioblastoma, craniopharngioma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, and tumors of the neck, spine, pancreas, liver, lungs, ovary, prostate, and bladder. Patients should be examined by a team of physicians to determine if they are candidates for CyberKnife treatment.
    Device Description
    The CyberKnife® Treatment Delivery System (CKTDS), subject of this submission, is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision™ Treatment Planning System (K161136) and iDMS™ Data Management System (K161144). The CKTDS uses a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem of the treatment delivery system provides X-rays of the treatment area that lets the user know the position of the target. The CyberKnife® Treatment Delivery System uses skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Tracking for dynamic positioning and pointing of the linear accelerator. The fixed aperture, variable aperture, and multileaf collimators are available as various beam-limiting secondary collimators.
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