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modeification to iplan rt dose
Brainlab Ag
Summary: Modeification to iPlan RT Dose is a treatment planning system by Brainlab Ag, primarily used in stereotactic radiosurgery and radiotherapy. Key evidence highlights its role in improving dose calculation accuracy.
FDA Clearance Information
Pathway
510K
Number
K080888 ↗
Decision Date
June 11, 2008
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The device received FDA clearance through the 510(k) pathway on June 11, 2008. It is manufactured by Brainlab Ag and classified as a Class 2 device under product code MUJ.
What It Is
Modeification to iPlan RT Dose is a treatment planning system designed for precise dose calculation in stereotactic radiosurgery and radiotherapy. It is intended for use in clinical settings to enhance treatment accuracy.
Clinical Applications
Commonly used in scenarios requiring precise radiation dose delivery, such as in the treatment of cranial arteriovenous malformations and lung cancer. It aids in optimizing treatment plans for radiosurgery and radiotherapy.
Evidence Summary
The literature includes a mix of retrospective and prospective studies, with a total of 10 peer-reviewed articles published between 2015 and 2024. These studies focus on dosimetric evaluations and treatment planning accuracy.
Reported Outcomes
Published studies report improvements in treatment coverage parameters and plan quality metrics when using the iPlan RT Dose system. Dosimetric comparisons highlight its accuracy in stereotactic radiosurgery/radiotherapy plans.
Safety Profile
Reported complications include potential discrepancies in dose calculations between different algorithms. However, no significant adverse events have been documented in the provided studies.
Evidence Limitations
The evidence is primarily retrospective, with limited prospective data. Further research is needed to validate findings across diverse patient populations and treatment settings.
Frequently Asked Questions
What are the clinical indications for modeification to iPlan RT Dose?
It is indicated for use in stereotactic radiosurgery and radiotherapy, particularly in cases requiring precise dose calculations, such as cranial arteriovenous malformations and lung cancer.
What outcomes have been reported in clinical studies?
Studies report improved treatment coverage parameters and plan quality metrics, demonstrating the system's accuracy in dose calculations.
What complications have been reported?
Reported complications include potential dose calculation discrepancies between different algorithms, though no significant adverse events have been noted.
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.