đź“‹ FDA Reference
helax-tms v 5 1 radiation therapy treatment planning system
Mds Nordion
Summary: The helax-tms v 5 1 is a radiation therapy treatment planning system used primarily by oncologists to plan and optimize radiation doses for cancer patients. It aids in ensuring precise targeting of tumors while minimizing exposure to surrounding healthy tissues.
FDA Clearance Information
Pathway
510K
Number
K010682 ↗
Decision Date
June 5, 2001
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The helax-tms v 5 1 was cleared through the FDA 510(k) pathway on June 5, 2001. Manufactured by Mds Nordion, this device is classified as Class 2 under product code MUJ.
What It Is
The helax-tms v 5 1 is a sophisticated software system designed for radiation therapy treatment planning. It allows clinicians to simulate and optimize radiation dose distributions for cancer treatment. By using advanced algorithms, it helps in creating detailed plans that maximize tumor control while protecting normal tissues, which is crucial in achieving effective and safe radiation therapy outcomes.
Clinical Applications
This device is primarily used in oncology settings, particularly in hospitals and cancer treatment centers. Radiation oncologists and medical physicists utilize it to design treatment plans for patients undergoing radiotherapy. It is applicable across various cancer types, including but not limited to breast, prostate, and head and neck cancers, where precision in radiation delivery is critical.
Indications for Use
The helax-tms v 5 1 is indicated for use in planning radiation therapy treatments. It is suitable for patients requiring precise radiation dosing, typically those with localized tumors where targeted therapy can improve outcomes and reduce side effects.
Practical Considerations
The system integrates with existing radiotherapy equipment and imaging modalities. Clinicians should ensure compatibility with their current systems and may need training to utilize its full capabilities effectively. Regular updates and maintenance are recommended to keep the software running optimally.
Frequently Asked Questions
What is helax-tms v 5 1 used for?
It is used for planning and optimizing radiation therapy treatments for cancer patients.
What specialties typically use this device?
Radiation oncologists and medical physicists in oncology settings use this device.
What are the FDA-cleared indications?
It is cleared for planning radiation therapy treatments, particularly for patients with localized tumors requiring precise dosing.
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.