📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in high-dose-rate brachytherapy treatment of prostate cancer.
- Use with compatible HDR brachytherapy systems for localized radiation treatment of the prostate.
Clinical Applications
- Planning and supporting HDR brachytherapy for prostate cancer.
- Supporting temporary placement and treatment delivery through prostate brachytherapy catheters or applicators.
- Use in radiation oncology departments and specialized cancer treatment centers with compatible HDR equipment.
Practical Considerations
- Compatibility with the installed HDR afterloading system, treatment-planning software and associated prostate brachytherapy equipment must be confirmed before use.
- Use requires trained radiation oncologists, medical physicists and radiation therapy staff familiar with HDR brachytherapy and treatment-planning quality assurance.
- Treatment commonly uses transperineal catheter or needle placement with ultrasound or other imaging guidance; the module itself does not replace imaging, applicators or an HDR source-delivery system.
- The module is not an MRI implant or an independently implanted device. MRI safety depends on the complete treatment setup, including needles, catheters, applicators and other accessories.
- Patient selection, contraindications, anesthesia or sedation, radiation dose and follow-up are determined by the treating radiation oncology team.
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.