đź“Š Evidence-Based Reference
iplan rt
Brainlab Ag
Summary: The iPlan RT by Brainlab Ag is a treatment planning system primarily used for stereotactic radiosurgery. Key evidence highlights its use in treating brain metastases with advanced dose calculation algorithms.
FDA Clearance Information
Pathway
510K
Number
K103246 ↗
Decision Date
March 16, 2011
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The iPlan RT received FDA clearance through the 510(k) pathway on March 16, 2011. It is manufactured by Brainlab Ag and is classified as a Class 2 device under product code MUJ.
What It Is
The iPlan RT is a sophisticated treatment planning system designed for stereotactic radiosurgery. It utilizes advanced algorithms for precise dose calculations, aiding in the treatment of complex conditions such as brain metastases.
Clinical Applications
The iPlan RT is commonly used in clinical settings for planning and executing stereotactic radiosurgery, particularly for patients with multiple brain metastases. It is also applicable in scenarios requiring precise dose delivery, such as lung cancer with respiratory tumor motion.
Evidence Summary
The available literature includes various study types such as RCTs, prospective, and retrospective studies, with a total of 9 studies published between 2013 and 2022.
Reported Outcomes
Published studies report that the iPlan RT system enhances treatment accuracy for brain metastases using advanced algorithms like Monte Carlo calculations. It has shown improved detection and treatment planning capabilities in stereotactic radiosurgery compared to conventional methods.
Safety Profile
Reported complications include potential inaccuracies in dose delivery when using less advanced algorithms. However, no significant adverse events directly related to the iPlan RT system were highlighted in the studies.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the iPlan RT system. Further research is needed to explore long-term outcomes and comparative effectiveness against newer technologies.
Frequently Asked Questions
What are the clinical indications for iPlan RT?
The iPlan RT is indicated for use in stereotactic radiosurgery, particularly for treating brain metastases and other conditions requiring precise dose calculations.
What outcomes have been reported in clinical studies?
Studies have reported improved treatment accuracy and planning capabilities for brain metastases using the iPlan RT system, particularly with advanced dose calculation algorithms.
What complications have been reported?
Safety data from evidence indicate potential inaccuracies with less advanced algorithms, but no significant adverse events directly related to the iPlan RT system were reported.
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.