đź“‹ FDA Reference
radionics xknife hdrt system
Integra Radionics
Summary: The Radionics XKnife HDRT System is a medical device used in radiation therapy, particularly for precise targeting of tumors. It is primarily used by radiation oncologists in clinical settings.
FDA Clearance Information
Pathway 510K
Number K083414 ↗
Decision Date March 2, 2009
Product Code MUJ
Device Class Class 2
Evidence 0 studies
The Radionics XKnife HDRT System was cleared by the FDA via the 510(k) pathway on March 2, 2009. Manufactured by Integra Radionics, it is classified as a Class 2 device under product code MUJ.
What It Is
The Radionics XKnife HDRT System is a high-dose rate therapy device designed for delivering precise radiation treatment to tumors. It utilizes advanced imaging and targeting technology to focus radiation on cancerous tissues while minimizing exposure to surrounding healthy tissues. This system is integral in stereotactic radiosurgery and radiotherapy, offering clinicians a tool for non-invasive treatment of various cancers.
Clinical Applications
This device is commonly used in oncology settings, particularly in the treatment of brain tumors, spinal tumors, and other localized cancers requiring precise radiation delivery. Radiation oncologists use the XKnife HDRT System in both hospital and outpatient settings to perform stereotactic radiosurgery and radiotherapy. It is suitable for patients who require targeted radiation therapy, often as an alternative to traditional surgery.
Indications for Use
The FDA indications for the Radionics XKnife HDRT System include its use in delivering high-dose radiation therapy to specific tumor sites. It is intended for patients with tumors that are accessible and can benefit from precise, high-dose radiation treatment.
Practical Considerations
Clinicians should consider the system's compatibility with existing imaging and radiation delivery equipment. Proper training in stereotactic techniques is essential for optimal use. The system's precision requires careful planning and setup to ensure accurate targeting of the treatment area.
Frequently Asked Questions
What is the Radionics XKnife HDRT System used for?
It is used for delivering precise high-dose radiation therapy to tumors, often in stereotactic radiosurgery.
What specialties typically use this device?
Radiation oncologists and medical physicists in oncology departments use this device.
What are the FDA-cleared indications?
The device is indicated for delivering high-dose radiation therapy to specific tumor sites, particularly where precision is crucial.
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.