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hdrplus add in prostate module for hdrplus
Eckert & Ziegler Bebig
Summary: The HDRplus add-in prostate module is a medical device used for high-dose-rate brachytherapy in prostate cancer treatment. It is primarily used by radiation oncologists in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K123263 ↗
Decision Date
April 4, 2013
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The HDRplus add-in prostate module by Eckert & Ziegler Bebig was cleared through the FDA 510(k) pathway on April 4, 2013. It is classified as a Class 2 device under product code MUJ.
What It Is
The HDRplus add-in prostate module is a specialized device used in high-dose-rate (HDR) brachytherapy for treating prostate cancer. It allows precise delivery of radiation directly to the prostate, minimizing exposure to surrounding healthy tissues. The device integrates with existing HDR brachytherapy systems to enhance treatment accuracy and efficacy.
Clinical Applications
This device is commonly used in the treatment of localized prostate cancer. It is typically utilized in radiation oncology departments within hospitals or specialized cancer treatment centers. The device is suitable for adult male patients diagnosed with prostate cancer, and it is often part of a comprehensive treatment plan that may include surgery or external beam radiation therapy.
Indications for Use
The HDRplus add-in prostate module is indicated for use in patients with prostate cancer requiring localized radiation treatment. It is designed to deliver high-dose-rate brachytherapy, which is a form of internal radiation therapy.
Practical Considerations
Clinicians should ensure compatibility with existing HDR brachytherapy systems. Proper training in the use of this module is essential for optimizing treatment outcomes. The device is typically used in conjunction with imaging techniques to guide accurate placement and radiation delivery.
Frequently Asked Questions
What is the HDRplus add-in prostate module used for?
It is used for delivering high-dose-rate brachytherapy in the treatment of prostate cancer.
What specialties typically use this device?
Radiation oncologists and medical physicists typically use this device in cancer treatment centers.
What are the FDA-cleared indications?
The device is indicated for high-dose-rate brachytherapy in patients with prostate cancer.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.