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cyberknife robotic radiosurgery system
Accuray
Summary: The CyberKnife Robotic Radiosurgery System is a non-invasive treatment device primarily used for stereotactic radiosurgery. Key evidence highlights its efficacy in treating brain metastases and schwannomas.
FDA Clearance Information
Pathway
510K
Number
K062967 ↗
Decision Date
October 30, 2006
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The CyberKnife Robotic Radiosurgery System was cleared by the FDA via the 510(k) pathway on October 30, 2006. It is manufactured by Accuray and classified as a Class 2 device.
What It Is
The CyberKnife Robotic Radiosurgery System is a robotic system designed for delivering precise, high-dose radiation therapy to tumors. It is used in stereotactic radiosurgery, allowing for non-invasive treatment of both intracranial and extracranial lesions.
Clinical Applications
Common clinical scenarios for the CyberKnife include treatment of brain metastases, vestibular schwannomas, and other tumors requiring precise radiation delivery. It is particularly useful in cases where traditional surgery is not feasible.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as cohort studies and evaluations of tracking systems, published between 2022 and 2025.
Reported Outcomes
Published studies report that the CyberKnife system provides effective local control and overall survival rates in patients with large brain metastases. It has also shown positive long-term outcomes in treating vestibular schwannomas and jugular foramen schwannomas.
Safety Profile
Reported complications include challenges in balancing efficacy and toxicity, particularly in larger lesions. The system's respiratory tracking accuracy has been evaluated to ensure safety during treatment of moving targets.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for further research on long-term outcomes and comparative studies with other treatment modalities. More data on the system's efficacy in diverse patient populations is needed.
Frequently Asked Questions
What are the clinical indications for CyberKnife Robotic Radiosurgery System?
The CyberKnife is indicated for the treatment of brain metastases, vestibular schwannomas, and other tumors requiring precise radiation therapy.
What outcomes have been reported in clinical studies?
Studies have reported effective local control and survival rates in brain metastases and positive outcomes in schwannoma treatments.
What complications have been reported?
Safety data indicates potential complications related to balancing efficacy and toxicity, particularly in treating larger lesions.
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.