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tomotherapy treatment system
Tomotherapy
Summary: The tomotherapy treatment system is a radiation therapy device used primarily for image-guided radiotherapy. Key evidence highlights its dosimetric performance and workflow optimization.
FDA Clearance Information
Pathway
510K
Number
K112446 ↗
Decision Date
October 7, 2011
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The tomotherapy treatment system was cleared by the FDA via the 510(k) pathway on October 7, 2011. It is manufactured by Tomotherapy and classified as a Class 2 device.
What It Is
The tomotherapy treatment system integrates computed tomography (CT) imaging with radiation therapy delivery, allowing for precise targeting of tumors. It is intended for use in image-guided radiotherapy to enhance treatment accuracy.
Clinical Applications
Commonly used in the treatment of various cancers, the tomotherapy system is particularly beneficial in scenarios requiring precise dose delivery, such as head and neck, lung, and prostate cancers.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, retrospective analyses, and case series, conducted between 2021 and 2024. These studies explore dosimetric performance, workflow optimization, and treatment efficacy.
Reported Outcomes
Published studies report that the tomotherapy system offers improved dosimetric performance compared to traditional methods, particularly in complex cases like angiosarcoma of the scalp. It also enhances treatment accuracy and reduces setup deviations.
Safety Profile
Reported complications include potential setup deviations and treatment time variations, which can impact overall treatment quality. However, surface-guided techniques have been shown to mitigate these issues.
Evidence Limitations
Current evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to explore long-term outcomes and comparative effectiveness with other radiotherapy systems.
Frequently Asked Questions
What are the clinical indications for tomotherapy treatment system?
The tomotherapy treatment system is indicated for use in image-guided radiotherapy for various cancers, including head and neck, lung, and prostate cancers.
What outcomes have been reported in clinical studies?
Studies have reported improved dosimetric performance and treatment accuracy, particularly in complex cases like angiosarcoma of the scalp.
What complications have been reported?
Safety data indicate potential setup deviations and treatment time variations, though these can be mitigated with surface-guided techniques.
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.