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The RadiaPak™ Brachytherapy Applicator Balloon Device is a single use, non-sterile, disposable, inflatable, non-powered positioning device, manufactured without the use of latex, intended to be used on a daily treatment basis to position and stabilize the brachytherapy radiation delivery applicator within the vagina or rectum during brachytherapy radiation therapy procedures, x-ray, or computed tomography (CT) exam. The placement of the balloon device requires a physician directed healthcare professional.

The RadiaPak™ Device is designed to position and stabilize the brachytherapy applicator and to space the applicator surface from the targeted vaginal or rectal mucosa during computed tomography and brachytherapy procedures. The proposed device is a latex free balloon and can be inflated with either air or saline, is provided non-sterile, and is intended for single use.