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510(k) Data Aggregation
K Number
K973786Device Name
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
Manufacturer
NW RADIATION THERAPY PRODUCTS
Date Cleared
1998-01-02
(88 days)
Product Code
IWJ
Regulation Number
892.5650Why did this record match?
Applicant Name (Manufacturer) :
NW RADIATION THERAPY PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Precision Stepper and Needle Guide is intended for use with a rectal probe in ultrasound-guided prostate brachytherapy (transperineal radioactive seed implantation), and prostate gland voluming. The Precision Stepper and Needle Guide system is an accessory to an ultrasound system used for these medical procedures in a clinical setting.
Condition to be screened, monitored, treated or diagnosed. Prostate gland voluming and treatment of prostate cancer by transperineal brachytherapy
Physiological purpose. The Precision Stepper provides equipment support and quidance for a rectal probe. When used with its Needle Guide, an ultrasonic imaging system, and a rectal probe, the Precision Stepper and Needle Guide System is an accessory to clinical procedures for prostate gland voluming and ultrasound-guided radioactive seed implantation.
Device Description
The Precision Stepper and Needle Guide is a manually operated medical device used to provide mechanical support for the application of a radionuclide source into the prostate in the course of a brachytherapy procedure in a clinical setting. The Stepper guides and secures a rectal probe which is used for imaging of the prostate. The Stepper moves the transducer in precise increments, or steps. When used in conjunction with the Stepper, the Needle Guide is used to aid the clinician in guiding needles through a template into the prostate. Under the guidance of the ultrasound probe, these needles are used to implant radioactive seeds that irradiate the prostate in cancer therapy.
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