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510(k) Data Aggregation

    K Number
    K090349
    Device Name
    CLEARVUE PRONE BREAST TREATMENT TABLE
    Manufacturer
    ORBITAL THERAPY, LLC
    Date Cleared
    2009-03-09

    (26 days)

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

    ORBITAL THERAPY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ClearVue, a breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy systems. ClearVue is intended to be used to position and reposition patients for breast radiation therapy. ClearVue may be used with CT and MR scanners to acquire images for radiation therapy planning.
    Device Description
    ClearVue is a prone-breast table top attachment, which allows for multi-angle access to the treatment anatomy. This device is compatible with mainstream linear accelerators as well as compatible with most existing CT scanners. ClearVue is placed on top of the existing treatment or imaging modality couch. ClearVue does not have motors for mechanical motion. ClearVue is compatible with both left and right breast patients by the use of variable inserts. An optional support cushion is used should one find it necessary to tilt the patient. ClearVue passes through a standard CT opening with the patient on top (these range from 70 to 85 cm in diameter). The distance between the layer on which the patient rests and the layer which rests on the therapy system couch is 18 to 30 cm to accommodate most breast sizes. The table is made from carbon-fiber to minimize thickness and radiation absorption. A soft, cushion lining is attached to the patient layer for comfort.
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