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510(k) Data Aggregation

    K Number
    K121284
    Device Name
    CHABNER XRT GARMENTS
    Manufacturer
    BFFL CO. INC
    Date Cleared
    2013-06-14

    (410 days)

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

    BFFL CO. INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Chabner XRT™ Garments are intended to be used as an aid in the support of the patient during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures. The Chabner XRT™ Garments are not intended for pediatric use.
    Device Description
    The device is a non-sterile garment worn by patients as an aid in the support and positioning of patients during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures. There are three versions of the garment: 1) brassiere; 2) athletic style shorts; and 3} girdle. All versions of the device are devoid of metal and can be worn for use with all treatment or diagnostic machines without causing a bolus (i.e., the materials do not mimic the properties of tissue during a radiological procedure) or attenuation effect. All materials used in the device's construction are < 1 mm in thickness. Clear thermoplastic polyurethane (TPU) windows are incorporated into the device to enable clinicians to view index tattoos, the midline, bony landmarks, and other treatment parameters, as created by the light field that is projected by the treatment or diagnostic machine onto the patient's body. The compressive nature of the materials used in the device's construction, along with various adjustment features incorporated into the device, assist the clinician in positioning the body and to reproduce the desired body geometry, treatment position, and patient-to-machine alignment prior to each radiological procedure. Radiation passes through the TPU material without affecting therapy or diagnosis. Because the device is worn as a garment, they offer the added benefit of protecting the patient's dignity during such procedures that, in turn, increases the patient's overall comfort during the process.
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