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510(k) Data Aggregation

    K Number
    K143560
    Device Name
    CygneX I System
    Manufacturer
    Date Cleared
    2015-10-05

    (293 days)

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

    Accuthera Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CygneX I System is intended to provide treatment planning and surface-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. atteriovenous malformations), tumors and conditions of the brain and base of skull (BOS).
    Device Description
    The CygneX I System consists of therapeutic CygneX I Treatment Delivery Subsystem and the dedicated CygPlan I Treatment Planning Subsystem. The CygneX I Treatment Delivery Subsystem consists mainly of a Therapeutic Xray Generation Part, 6-Axis Manipulator Part, and X-ray Delivery Control Console Part. A linear accelerator with a variable collimator is incorporated in the X-ray head, the main portion of the Therapeutic X-ray Generation Part, which generates a very fine, highly- energized (6 MV) and controlled dose of X-ray beams. The variable secondary collimator is capable of delivering regular hexagonal fields, with the distances between the two opposite sides from 5mm to 30 mm, at 60 SAD. The CygPlan I Treatment Planning Subsystem provides the capability for forward and inverse planning from CT data. It provides a plan after physician approval, to the CygneX I Treatment Delivery Subsystem to deliver the treatment from the selected treatment nodes.
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