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tomotherapy treatment system fast optimizer
Tomotherapy
Summary: The tomotherapy treatment system fast optimizer is a medical device used for optimizing radiation therapy delivery. It is primarily used in intensity-modulated radiation therapy (IMRT) to enhance treatment efficiency. Key evidence highlights its role in improving dose distribution and reducing treatment time.
FDA Clearance Information
Pathway
510K
Number
K112776 ↗
Decision Date
December 22, 2011
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The tomotherapy treatment system fast optimizer was cleared by the FDA via the 510(k) pathway on December 22, 2011. It is manufactured by Tomotherapy and classified as a Class 2 device.
What It Is
The tomotherapy treatment system fast optimizer is designed to enhance the efficiency of radiation therapy delivery by optimizing the treatment planning process. It is used in clinical settings to improve the precision and speed of intensity-modulated radiation therapy (IMRT).
Clinical Applications
This device is commonly used in scenarios requiring precise radiation delivery, such as treating complex tumors where sparing surrounding healthy tissue is critical. It is particularly useful in cases requiring rapid treatment planning and delivery.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2022 and 2025. These studies focus on treatment planning optimization and efficiency improvements.
Reported Outcomes
Published studies report that the tomotherapy treatment system fast optimizer enhances dose distribution accuracy and reduces treatment delivery time. It has been shown to improve patient comfort by minimizing motion-induced uncertainties and optimizing energy layer usage.
Safety Profile
Reported complications include minimal adverse events, with studies primarily focusing on the optimization of treatment delivery rather than direct patient safety outcomes. Overall, the device is considered safe within the studied contexts.
Evidence Limitations
The evidence is limited by the relatively small number of studies directly addressing patient outcomes. Further research is needed to explore long-term safety and efficacy, as well as comparisons with other treatment optimization systems.
Frequently Asked Questions
What are the clinical indications for the tomotherapy treatment system fast optimizer?
The device is indicated for use in optimizing radiation therapy delivery, particularly in intensity-modulated radiation therapy (IMRT) for complex tumor cases.
What outcomes have been reported in clinical studies?
Studies have reported improved dose distribution accuracy and reduced treatment delivery time, enhancing overall treatment efficiency.
What complications have been reported?
Safety data from evidence indicate minimal adverse events, with a focus on treatment delivery optimization rather than direct patient safety outcomes.
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.