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sagiplan sagiplan prostate module add on sagiplan including prostate module
Eckert & Ziegler Bebig
Summary: The Sagiplan Prostate Module is an add-on for planning prostate brachytherapy procedures. It is used by urologists and radiation oncologists to optimize treatment plans for prostate cancer patients.
FDA Clearance Information
Pathway
510K
Number
K141900 ↗
Decision Date
May 20, 2015
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Sagiplan Prostate Module was cleared through the FDA 510(k) pathway on May 20, 2015. Manufactured by Eckert & Ziegler Bebig, it is a Class 2 device under product code MUJ.
What It Is
The Sagiplan Prostate Module is a software add-on designed for use in brachytherapy planning for prostate cancer. It assists clinicians in creating precise treatment plans by simulating the placement of radioactive seeds within the prostate gland. This module integrates with existing brachytherapy systems to enhance accuracy and treatment outcomes.
Clinical Applications
This device is primarily used in the field of radiation oncology and urology, specifically for patients undergoing prostate cancer treatment. It is utilized in hospital settings and specialized cancer treatment centers. The module aids in planning the optimal distribution of radioactive seeds to maximize tumor control while minimizing exposure to surrounding healthy tissues.
Indications for Use
The FDA-cleared indications for the Sagiplan Prostate Module involve its use in planning brachytherapy for prostate cancer patients. It is intended for use in patients diagnosed with localized prostate cancer who are candidates for brachytherapy.
Practical Considerations
Clinicians should ensure compatibility with their existing brachytherapy systems when integrating the Sagiplan Prostate Module. Proper training in the software's use is essential to maximize its benefits. The module supports various seed types and configurations, allowing for flexible treatment planning.
Frequently Asked Questions
What is Sagiplan Prostate Module used for?
It is used for planning prostate brachytherapy procedures to treat prostate cancer.
What specialties typically use this device?
Urologists and radiation oncologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for planning brachytherapy in patients with localized 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.