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helax-tms v 5 0 radiation therapy treatment planning system
Helax Ab
Summary: The Helax-TMS v5.0 is a radiation therapy treatment planning system used primarily by oncologists and radiation therapists to plan and optimize radiation treatments for cancer patients.
FDA Clearance Information
Pathway
510K
Number
K993766 ↗
Decision Date
December 8, 1999
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Helax-TMS v5.0 was cleared through the FDA 510k pathway on December 8, 1999. It is manufactured by Helax Ab and classified as a Class 2 device under product code MUJ.
What It Is
The Helax-TMS v5.0 is a sophisticated software system designed to assist in the planning of radiation therapy treatments. It allows clinicians to create detailed treatment plans that optimize the delivery of radiation to target cancerous tissues while minimizing exposure to surrounding healthy tissues. The system integrates with imaging data to provide precise mapping and dose calculations.
Clinical Applications
This device is commonly used in oncology departments within hospitals and specialized cancer treatment centers. It is utilized by radiation oncologists and medical physicists to plan treatments for a variety of cancers, including but not limited to breast, prostate, and lung cancers. The system supports both external beam radiation therapy and brachytherapy planning.
Indications for Use
The Helax-TMS v5.0 is indicated for use in the planning of radiation therapy treatments for patients with cancer. It is designed to assist clinicians in optimizing treatment plans to effectively target tumors while sparing healthy tissue.
Practical Considerations
Clinicians should ensure compatibility with existing imaging systems and verify that the software is updated to the latest version for optimal performance. Familiarity with the system's interface and planning algorithms is crucial for effective use. Regular calibration and validation of the system are recommended to maintain accuracy.
Frequently Asked Questions
What is Helax-TMS v5.0 used for?
Helax-TMS v5.0 is used for planning radiation therapy treatments for cancer patients, helping to optimize the delivery of radiation to tumors.
What specialties typically use this device?
Radiation oncologists and medical physicists typically use this device in oncology departments and cancer treatment centers.
What are the FDA-cleared indications?
The device is cleared for planning radiation therapy treatments for patients with cancer, aiming to target tumors while minimizing exposure to healthy tissues.
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.