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variseed 7 0
Varian Medical Systems
Summary: Variseed 7 0 is a medical device used in the planning and delivery of brachytherapy for prostate cancer. It is primarily used by radiation oncologists to ensure accurate seed placement and dosimetry.
FDA Clearance Information
Pathway
510K
Number
K012017 ↗
Decision Date
July 12, 2001
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Variseed 7 0 was cleared through the FDA 510k pathway on July 12, 2001. Manufactured by Varian Medical Systems, it is a Class 2 device under product code MUJ.
What It Is
Variseed 7 0 is a software-based system designed to assist in the planning and execution of brachytherapy for prostate cancer. It provides real-time dosimetry and seed placement guidance to ensure optimal radiation delivery. The system helps clinicians visualize isodose patterns and adjust seed placement intraoperatively, potentially improving treatment outcomes.
Clinical Applications
This device is commonly used in the treatment of prostate cancer through brachytherapy, a form of internal radiation therapy. It is typically utilized in oncology centers and hospitals by radiation oncologists and medical physicists. The system is particularly beneficial for patients undergoing prostate seed implantation, where precise dosimetry and seed placement are critical for effective treatment.
Indications for Use
The Variseed 7 0 is indicated for use in patients with prostate cancer who are candidates for brachytherapy. It assists in planning and delivering radiation therapy by providing real-time feedback on seed placement and dosimetry.
Practical Considerations
Clinicians should ensure compatibility with existing brachytherapy equipment and be trained in the use of the software for optimal results. The system requires careful calibration and understanding of dosimetric principles to maximize its benefits.
Related Literature
The linked study investigated isodose patterns in patients with inadequate prostate brachytherapy coverage. It highlighted the importance of a real-time dosimetry system in identifying inadequate implants and guiding corrective seed placement. While the study demonstrated potential improvements in implant dose distributions, it noted limitations in accurate registration with prostatic volume.
Frequently Asked Questions
What is Variseed 7 0 used for?
Variseed 7 0 is used for planning and delivering brachytherapy in prostate cancer treatment, ensuring accurate seed placement and dosimetry.
What specialties typically use this device?
Radiation oncologists and medical physicists typically use this device in oncology centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients with prostate cancer undergoing brachytherapy, assisting in seed placement and dosimetry.
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.