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focus radiation treatment planning system
Computerized Medical Systems
Summary: The focus radiation treatment planning system is a device used for planning radiation therapy. It is primarily used to optimize treatment plans for cancer patients. Key evidence highlights its role in improving treatment precision and consistency.
FDA Clearance Information
Pathway
510K
Number
K020027 ↗
Decision Date
October 8, 2002
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The focus radiation treatment planning system was cleared by the FDA via the 510(k) pathway on October 8, 2002. It is manufactured by Computerized Medical Systems and is classified as a Class 2 device.
What It Is
The focus radiation treatment planning system is a software tool designed to assist clinicians in planning radiation therapy treatments. It helps optimize the delivery of radiation doses to target tissues while minimizing exposure to surrounding healthy tissues.
Clinical Applications
This device is commonly used in oncology settings for planning treatments in various cancers, including brain, head and neck, thorax, abdomen, and pelvis. It is particularly useful in complex cases requiring precise dose distribution.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs, prospective, and retrospective studies. These studies span from 2019 to 2024, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the focus radiation treatment planning system enhances the precision of radiation dose delivery and improves treatment consistency across different clinical sites. It has been shown to reduce clinical workload through automation and improve patient outcomes by optimizing treatment plans.
Safety Profile
Reported complications include the potential for inaccuracies in dose calculation if the system is not properly calibrated. However, no significant adverse events directly attributed to the device have been documented in the reviewed studies.
Evidence Limitations
The evidence is limited by the heterogeneity of study designs and the lack of large-scale randomized controlled trials. Further research is needed to evaluate long-term outcomes and to standardize protocols across different clinical settings.
Frequently Asked Questions
What are the clinical indications for focus radiation treatment planning system?
The device is indicated for use in planning radiation therapy for various cancers, including those in the brain, head and neck, thorax, abdomen, and pelvis.
What outcomes have been reported in clinical studies?
Studies have reported improved precision in radiation dose delivery and enhanced treatment consistency, leading to better patient outcomes.
What complications have been reported?
Safety data from evidence indicate potential inaccuracies in dose calculation if not properly calibrated, but no significant adverse events have been directly linked to the device.
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.