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cyberknife robotic radiosurgery system
Accuray
Summary: The CyberKnife Robotic Radiosurgery System is a non-invasive treatment device used primarily for stereotactic radiosurgery. Key evidence highlights its efficacy in treating brain metastases and other tumors with precision.
FDA Clearance Information
Pathway
510K
Number
K062514 ↗
Decision Date
September 28, 2006
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The CyberKnife Robotic Radiosurgery System was cleared by the FDA through the 510(k) pathway on September 28, 2006. It is manufactured by Accuray and classified as a Class 2 device under product code MUJ.
What It Is
The CyberKnife Robotic Radiosurgery System is a robotic radiosurgery device designed to deliver precise, high-dose radiation to tumors with sub-millimeter accuracy. It is intended for the treatment of various types of tumors, including those in the brain, spine, lung, and liver.
Clinical Applications
Common clinical scenarios for the CyberKnife system include treating brain metastases, vestibular schwannomas, and other intracranial and extracranial tumors. 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 retrospective analyses. The studies span from 2022 to 2025, providing insights into the system's clinical efficacy and safety.
Reported Outcomes
Published studies report that the CyberKnife system achieves effective local control of tumors, particularly in brain metastases and vestibular schwannomas. Long-term outcomes indicate favorable survival rates and tumor control with minimal invasiveness.
Safety Profile
Reported complications include challenges in balancing efficacy and toxicity, particularly in larger lesions. However, the system's precision minimizes damage to surrounding healthy tissue, reducing the risk of adverse effects.
Evidence Limitations
Evidence gaps include the need for more randomized controlled trials to establish long-term efficacy and safety across diverse patient populations. Further research is needed to optimize treatment protocols for larger and more complex tumors.
Frequently Asked Questions
What are the clinical indications for CyberKnife Robotic Radiosurgery System?
The CyberKnife system is indicated for the treatment of brain metastases, vestibular schwannomas, and other tumors where precision radiosurgery is required.
What outcomes have been reported in clinical studies?
Studies report effective local tumor control and favorable survival rates, particularly in brain metastases and vestibular schwannomas.
What complications have been reported?
Reported complications include potential toxicity in larger lesions, though the system's precision generally minimizes adverse effects.
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.