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cyberknife system for sterotactic radiosurgery radiotherapy
Accuray
Summary: The CyberKnife System is a robotic radiosurgery system used for delivering precise radiation therapy. It is primarily used by oncologists and radiologists for treating tumors and other medical conditions requiring high precision.
FDA Clearance Information
Pathway 510K
Number K032345 ↗
Decision Date September 3, 2003
Product Code MUJ
Device Class Class 2
Evidence 0 studies
The CyberKnife System received FDA clearance through the 510(k) pathway on September 3, 2003. Manufactured by Accuray, it is classified as a Class 2 medical device under product code MUJ.
What It Is
The CyberKnife System is a non-invasive, robotic radiosurgery system designed to deliver high doses of radiation with sub-millimeter precision. It utilizes a linear accelerator mounted on a robotic arm, allowing for flexible treatment angles and real-time imaging to track and adjust for patient and tumor movement. This system is particularly useful for treating tumors in sensitive or hard-to-reach areas where traditional surgery is not feasible.
Clinical Applications
The CyberKnife System is commonly used in oncology for treating brain, spine, lung, liver, pancreas, and prostate tumors. It is particularly beneficial in settings where precision is critical, such as in stereotactic radiosurgery (SRS) and stereotactic body radiotherapy (SBRT). Patients who are not candidates for conventional surgery due to medical conditions or tumor location often benefit from this technology.
Indications for Use
The FDA-cleared indications for the CyberKnife System include the treatment of tumors and lesions in various parts of the body, particularly those requiring high precision. It is suitable for patients with tumors in sensitive areas or those who cannot undergo traditional surgery.
Practical Considerations
The CyberKnife System requires careful planning and imaging to ensure precise targeting. It is compatible with various imaging modalities for treatment planning and real-time tracking. Clinicians should be trained in the system's operation and patient positioning techniques to maximize treatment efficacy.
Frequently Asked Questions
What is the CyberKnife System used for?
The CyberKnife System is used for delivering precise radiation therapy to treat tumors and lesions in various parts of the body.
What specialties typically use this device?
Oncologists and radiologists primarily use the CyberKnife System, particularly those specializing in radiosurgery and radiotherapy.
What are the FDA-cleared indications?
The CyberKnife System is FDA-cleared for treating tumors and lesions in areas requiring high precision, such as the brain, spine, and other sensitive locations.
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.