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integra radionics xknife rt 4
Integra Radionics
Summary: The Integra Radionics XKnife RT 4 is a medical device used in radiation therapy for precise targeting of treatment areas. It is primarily utilized by oncologists and radiation therapists.
FDA Clearance Information
Pathway
510K
Number
K061893 ↗
Decision Date
July 25, 2006
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Integra Radionics XKnife RT 4 was cleared via the FDA 510(k) pathway on July 25, 2006. It is manufactured by Integra Radionics and classified as a Class 2 medical device.
What It Is
The Integra Radionics XKnife RT 4 is a stereotactic radiosurgery system designed to deliver precise doses of radiation to targeted areas, minimizing exposure to surrounding healthy tissue. It integrates advanced imaging and targeting technologies to enhance accuracy in radiation therapy. This device is particularly useful in treating small to medium-sized tumors and vascular malformations in the brain.
Clinical Applications
Commonly used in oncology settings, the XKnife RT 4 is employed in the treatment of brain tumors, arteriovenous malformations, and other conditions requiring precise radiation delivery. It is typically used by radiation oncologists and neurosurgeons in hospital-based radiation therapy departments. The device is suitable for adult and pediatric patients requiring targeted radiation therapy.
Indications for Use
The FDA indications for the XKnife RT 4 include its use in delivering focused radiation therapy to treat specific conditions like brain tumors and vascular malformations. It is intended for patients who require precise targeting to avoid damage to healthy tissues.
Practical Considerations
The XKnife RT 4 system is compatible with various imaging modalities to enhance targeting accuracy. Clinicians should be trained in stereotactic techniques to optimize the device's capabilities. Regular calibration and maintenance are essential to ensure precise operation.
Frequently Asked Questions
What is Integra Radionics XKnife RT 4 used for?
It is used for delivering precise radiation therapy to treat brain tumors and vascular malformations.
What specialties typically use this device?
Radiation oncologists and neurosurgeons primarily use this device in oncology settings.
What are the FDA-cleared indications?
The device is indicated for use in stereotactic radiosurgery for treating brain tumors and arteriovenous malformations.
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.