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510(k) Data Aggregation

    K Number
    K211001
    Device Name
    C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner
    Manufacturer
    MEDTEC, Inc. dba CIVCO Medical Solutions and CIVCO
    Date Cleared
    2021-05-20

    (48 days)

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

    MEDTEC, Inc. dba CIVCO Medical Solutions and CIVCO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. Device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. The device is not intended for use with patients under 12 years of age.
    Device Description
    The Breastboard and Overhead Arm Positioner are used to position the patient during external beam radiation therapy. The Breastboard is comprised of a Base, Back Support, and Bottom Stop. The Base serves as the foundation of the assembly and provides a mounting surface for the Back Support, Angle Supports, and the Bottom Stop. The inferior end of the Back Support is mounted to the Base while the superior end of the Back Support is raised/lowered as needed for patient setup using Low Angle Supports. The Bottom Stop is located near the inferior end of the Base and prevents the patient from sliding down the Board. The Low Angle Support is used to position the Back Support at 5°, 7.5°, 10°, 12.5°, and 15° angles. Features on the High Angle Support receive the cutouts on the Low Angle Support and hold the angular position of the Support. The High Angle Support is used to position the Back Support at 17.5°, 20°, 22.5°, and 25° angles. Features on the Base receive the cutouts on the High Angle Support and hold the angular position of the Support. A Lock provides a method of locking the Back Support to the Base at 0° to facilitate easier handling and storage of the Breastboard. The Overhead Arm Positioner provides support for the patient's arms above the head and is attached to the Back Support via a locking assembly. The Overhead Arm Positioner adjusts longitudinally on the Back Support to accommodate a variety of patient sizes. A Hand Grip is mounted on the Overhead Arm Positioner and the location of the Hand Grip is adjustable longitudinally. A Head Support rests on a recessed area of the Overhead Arm Positioner and provides a cushion for positioning of the head of the patient. The Head Support can also be mounted directly on the Breastboard. A Thermoplastic Frame may also be mounted to the Overhead Arm Positioner to enable attachment of a thermoplastic mask for additional patient support. The Breastboard and Overhead Arm Positioner can also be used for supporting and elevating patients undergoing treatment who cannot lay down flat on the table due to their habitus. The Breastboard and Overhead Arm Positioner are reusable devices that are provided nonsterile.
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