đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as part of a stereotactic radiation therapy system to plan and deliver precisely targeted radiation treatment.
- Intended for treatment of defined lesions or other targets for which focused radiation therapy is clinically appropriate.
- Use with compatible imaging, treatment-planning, and radiation-delivery equipment according to the cleared system configuration and labeling.
Clinical Applications
- Stereotactic radiation treatment planning for selected intracranial targets.
- Focused radiation treatment of appropriately selected brain lesions.
- Treatment planning in radiation oncology when precise target localization and dose delivery are required.
- Use with image-guided or stereotactic localization as specified by the treatment protocol and system configuration.
Reported off-label uses
- Selected extracranial stereotactic body radiation therapy applications have been described for this device type, but use depends on the specific cleared configuration, treatment-planning software, and institutional protocols.
- Fractionated stereotactic radiation therapy for selected lesions has been reported in clinical practice, although the exact indication should be verified against current labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- This is a radiation therapy planning and delivery system, not an implantable device or standalone radiation source.
- Treatment requires immobilization or stereotactic localization, imaging, treatment planning, radiation dose verification, and administration by trained radiation oncology personnel.
- Compatibility with CT, MRI, angiography, treatment-planning software, and radiation-delivery equipment depends on the specific system configuration; verify interfaces before use.
- MRI safety applies to the complete clinical setup and any associated frame, immobilization device, accessories, and equipment. Do not assume the system or accessories are MRI safe without checking manufacturer labeling.
- Regular calibration, quality assurance, software validation, and preventive maintenance are required. Contraindications and limitations depend on the target, patient positioning, imaging quality, prior radiation exposure, and the cleared configuration.
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.