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cybernife stereotactic radiosurgery system
Accuray
Summary: The CyberKnife Stereotactic Radiosurgery System is a non-invasive device used for delivering precise radiation therapy to tumors. It is primarily used by radiation oncologists and neurosurgeons to treat cancer patients.
FDA Clearance Information
Pathway
510K
Number
K051941 ↗
Decision Date
August 9, 2005
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The CyberKnife System, manufactured by Accuray, was cleared by the FDA via the 510k pathway on August 9, 2005. It is classified as a Class 2 medical device under product code MUJ.
What It Is
The CyberKnife Stereotactic Radiosurgery System is a robotic radiosurgery system designed to deliver high doses of radiation with sub-millimeter accuracy. It uses real-time imaging to track tumor movement and adjust the radiation beams accordingly, minimizing damage to surrounding healthy tissue. This system is particularly useful for treating tumors in the brain, spine, and other areas where precision is critical.
Clinical Applications
The CyberKnife System is commonly used in oncology settings for the treatment of various types of cancer, including brain, spine, lung, liver, pancreas, and prostate tumors. It is especially beneficial in cases where traditional surgery is not feasible or when patients are seeking a non-invasive treatment option. The system is typically used in outpatient settings, allowing patients to return home the same day.
Indications for Use
The FDA-cleared indications for the CyberKnife System include the treatment of tumors and lesions in the brain and body. It is suitable for patients who require precise targeting of radiation, such as those with inoperable or surgically complex tumors.
Practical Considerations
Clinicians should consider the CyberKnife System for patients who need precise, non-invasive treatment options. The system is compatible with a wide range of tumor sizes and locations, and its robotic arm allows for flexibility in treatment angles. Proper patient positioning and imaging are crucial for optimal outcomes.
Frequently Asked Questions
What is the CyberKnife Stereotactic Radiosurgery System used for?
The CyberKnife System is used for delivering precise radiation therapy to treat tumors and lesions in the brain and body.
What specialties typically use this device?
Radiation oncologists and neurosurgeons typically use the CyberKnife System in oncology and neurosurgery settings.
What are the FDA-cleared indications?
The CyberKnife System is indicated for the treatment of tumors and lesions in the brain and body, particularly where precision is critical.
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.