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510(k) Data Aggregation
K Number
K042110Device Name
BEAMCATH
Manufacturer
BEAMPOINT AB
Date Cleared
2005-02-25
(204 days)
Product Code
EZL, IYE
Regulation Number
876.5130Why 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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