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precision treatment planning system
Accuray
Summary: The Precision Treatment Planning System by Accuray is a device used for radiation therapy planning, particularly in adaptive and stereotactic treatments. Key evidence highlights its integration with real-time tracking systems and dose recalculation accuracy.
FDA Clearance Information
Pathway
510K
Number
K161136 ↗
Decision Date
June 24, 2016
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Precision Treatment Planning System was cleared by the FDA through the 510(k) pathway on June 24, 2016. It is manufactured by Accuray and is classified as a Class 2 medical device.
What It Is
The Precision Treatment Planning System is a sophisticated software platform designed for planning radiation therapy treatments. It is used to optimize dose delivery in various clinical scenarios, including adaptive radiation therapy and stereotactic radiosurgery.
Clinical Applications
Common clinical scenarios for this device include planning treatments for brain metastases, nasopharyngeal carcinoma, and other complex cases requiring precise dose calculations and adaptive therapy adjustments.
Evidence Summary
The available literature includes 14 studies, comprising various study types such as retrospective analyses and phantom studies, published between 2023 and 2025. These studies focus on dose calculation accuracy and treatment efficacy.
Reported Outcomes
Published studies report that the Precision Treatment Planning System provides accurate dose calculations and effective integration with real-time tracking systems. It supports adaptive radiation therapy, enhancing treatment precision for complex cases.
Safety Profile
Reported complications include potential dosimetric inaccuracies due to discrete leaf width constraints in the multileaf collimator, which may affect treatment precision. No severe adverse events have been documented in the provided studies.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials and long-term outcome data. Further research is needed to explore the full potential of adaptive therapy features and to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Precision Treatment Planning System?
The device is indicated for use in radiation therapy planning, particularly in adaptive and stereotactic treatments for conditions like brain metastases and nasopharyngeal carcinoma.
What outcomes have been reported in clinical studies?
Studies have reported accurate dose calculations and effective integration with real-time tracking systems, supporting precise treatment delivery in complex cases.
What complications have been reported?
Reported complications include potential dosimetric inaccuracies due to the multileaf collimator's discrete leaf width, which may impact treatment precision.
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.