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510(k) Data Aggregation

    K Number
    K111299
    Device Name
    AXXENT RADIATION SHIELD - RIGID
    Date Cleared
    2011-07-20

    (72 days)

    Product Code
    Regulation Number
    892.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    XOFT, AN ICAD COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Use of the Axxent Radiation Shield - Rigid is indicated in cases in which protection of tissue and/or organs from x-radiation is desired. The Axxent Radiation Shield - Rigid can be used externally and internally, such as during intraoperative radiation therapy (IORT) when the treatment site is exposed surgically.
    Device Description
    The Axxent Radiation Shield - Rigid is an optional radiation shielding accessory to the Axxent Electronic Brachytherapy System (cleared under K072683) intended to protect tissue and/or organs from unwanted radiation. It is a rigid stainless steel pad placed over the area requiring shielding. It can be used on external patient surfaces, such as skin, as well internally during Intraoperative Radiation Therapy (IORT). The Axxent Radiation Shield - Rigid is fabricated entirely from 316L stainless steel (UNS S31603, ASTM A240/A240M). The shield is available in circular and ellipsoidal shapes in a range of various sizes. The Axxent Radiation Shield - Rigid is provided non-sterile and can be reused. The user must sterilize the device using steam sterilization before each use.
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