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510(k) Data Aggregation

    K Number
    K042110
    Device Name
    BEAMCATH
    Manufacturer
    BEAMPOINT AB
    Date Cleared
    2005-02-25

    (204 days)

    Product Code
    EZL, IYE
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEAMPOINT AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BeamCath is a positioning device used with external beam conformal radiation therapy for visualizing the prostate position during treatment of prostate cancer. The BeamCath is introduced into the urethra as is a sterile urological catheter and is retained in place by inflating the balloon tip. Its radiopaque markers aid in radiographic visualization of the prostate position for planning, simulation and treatment of prostate cancer using dose escalation radiotherapy.
    Device Description
    The BeamCath is a positioning device used with external beam conformal radiation therapy for visualizing the prostate position during treatment of prostate cancer. The BearnCath combines the function of a radiographic positioning device with the configuration of a urological Foley catheter. The BeamCath configuration and material composition are similar to urological catheters with a balloon retention mechanism. The device is disposable, sterile and intended for single use. The BeamCath is approximately 430 mm in length and 14 French diameter with a balloon size of 10 ml. The device consists of a PVC ficitiation in 1 1 renon alaxites in instillation of contrast into the bladder and air-inflation lumen for balloon function; PVC tubing with tantalum radiopaque markers; and a natural latex balloon retention mechanism. The BeamCath is introduced into the urethra as is a sterile urological catheter and is retained in place by inflating the balloon tip. Its radiopaque markers aid in radiographic visualization of the prostate position for planning, simulation and treatment of prostate cancer using dose escalation radiotherapy. Precise positioning of the prostate allows for more precise dose radiation treatment without excessive side effects to surrounding tissue.
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