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radionics xknife rt 3 with non stereotactic module
Radionics, A Division Of Tyco Healthcare Group Lp
Summary: The Radionics XKnife RT 3 is a radiotherapy device used primarily for stereotactic radiosurgery. It is FDA-cleared and supported by 10 studies, highlighting its efficacy in treating intracranial lesions.
FDA Clearance Information
Pathway
510K
Number
K041997 ↗
Decision Date
August 27, 2004
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Radionics XKnife RT 3 was cleared by the FDA via the 510(k) pathway on August 27, 2004. It is manufactured by Radionics, a division of Tyco Healthcare Group LP, and is classified as a Class 2 device.
What It Is
The Radionics XKnife RT 3 is a radiotherapy device designed for delivering precise radiation doses to intracranial lesions. It utilizes narrow photon beams arranged in 3-D configurations to target lesions non-invasively.
Clinical Applications
Commonly used in the treatment of acoustic neuromas and choroidal melanomas, the device is applied in scenarios where precise targeting of intracranial lesions is required, offering an alternative to invasive surgery.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, conducted between 2008 and 2016. These studies explore dosimetric comparisons and treatment efficacy.
Reported Outcomes
Published studies report that the Radionics XKnife RT 3 is effective in treating acoustic neuromas and choroidal melanomas, with fractionated stereotactic radiotherapy showing promise for large tumors. Dosimetric comparisons indicate favorable dose distributions.
Safety Profile
Reported complications include late radiation toxicities, which are compared between different treatment modalities. Safety profiles are generally favorable, with specific attention to minimizing radiation exposure to surrounding tissues.
Evidence Limitations
Evidence gaps include limited long-term follow-up data and a need for larger sample sizes in some studies. Further research is needed to explore the full range of clinical applications and optimize treatment protocols.
Frequently Asked Questions
What are the clinical indications for Radionics XKnife RT 3?
The device is indicated for the treatment of intracranial lesions, including acoustic neuromas and choroidal melanomas, using stereotactic radiosurgery.
What outcomes have been reported in clinical studies?
Studies report effective treatment of acoustic neuromas and choroidal melanomas, with favorable dosimetric outcomes and reduced need for invasive surgery.
What complications have been reported?
Safety data indicate late radiation toxicities as a potential complication, with efforts to minimize exposure to surrounding healthy tissues.
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.