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510(k) Data Aggregation

    K Number
    K140528
    Device Name
    TRUE BEAM, TRUE BEAM STX, EDGE
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Date Cleared
    2014-09-05

    (185 days)

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

    VARIAN MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrueBeam and Edge Systems are intended to provide stereotactic radiotherapy for lesions, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients. The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: bram and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as ung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carvinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavemous malformation, trigeninal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, pitutary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).
    Device Description
    The TrueBeam™ and Edge™ Radiotherapy Delivery Systems are medical linear accelerators that integrate the previously cleared Trilogy Radiotherapy system and associated accessories into a single device. The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
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