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leksell gammaplan
Elekta Instrument Ab
Summary: Leksell GammaPlan is a treatment planning system for radiosurgery, primarily used in conjunction with the Leksell Gamma Knife. Key evidence highlights its efficacy in dose calculation and treatment planning.
FDA Clearance Information
Pathway
510K
Number
K090972 ↗
Decision Date
July 20, 2009
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Leksell GammaPlan was cleared by the FDA via the 510(k) pathway on July 20, 2009. It is manufactured by Elekta Instrument Ab and classified as a Class 2 device under product code MUJ.
What It Is
Leksell GammaPlan is a software system designed for planning radiosurgical treatments using the Leksell Gamma Knife. It facilitates precise dose calculations and treatment planning for various intracranial conditions.
Clinical Applications
Commonly used in the treatment of brain tumors, arteriovenous malformations, and functional disorders, Leksell GammaPlan aids clinicians in developing accurate radiosurgical plans tailored to individual patient anatomy.
Evidence Summary
The literature includes 12 studies, ranging from 2020 to 2023, encompassing various study types such as RCTs and retrospective analyses. These studies focus on the system's dosimetric accuracy and integration with imaging modalities.
Reported Outcomes
Published studies report that Leksell GammaPlan provides reliable dose calculations and supports effective treatment planning. It has been shown to enhance the precision of radiosurgical interventions, particularly when incorporating advanced imaging techniques.
Safety Profile
Reported complications include challenges in integrating certain imaging modalities with the current version of the software. However, no significant adverse events directly related to the use of Leksell GammaPlan have been documented.
Evidence Limitations
The evidence highlights the need for further research on the integration of newer imaging technologies with Leksell GammaPlan. Some studies also note limitations in the software's compatibility with advanced imaging techniques.
Frequently Asked Questions
What are the clinical indications for Leksell GammaPlan?
Leksell GammaPlan is indicated for use in planning radiosurgical treatments for intracranial conditions such as tumors and arteriovenous malformations.
What outcomes have been reported in clinical studies?
Studies report effective dose calculation and treatment planning, with improved precision in radiosurgical interventions.
What complications have been reported?
Reported complications include integration challenges with certain imaging modalities, but no significant adverse events have been documented.
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.