đź“‹ FDA Reference
leksell gammaplan 4c with multiview
Elekta Instrument Ab
Summary: The Leksell GammaPlan 4C with MultiView is a treatment planning software used in stereotactic radiosurgery, primarily by neurosurgeons and radiation oncologists. It facilitates precise targeting of lesions in the brain using gamma rays.
FDA Clearance Information
Pathway
510K
Number
K042269 ↗
Decision Date
September 8, 2004
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Leksell GammaPlan 4C with MultiView, manufactured by Elekta Instrument Ab, was cleared by the FDA under 510k K042269 on September 8, 2004. It is a Class 2 medical device.
What It Is
The Leksell GammaPlan 4C with MultiView is a sophisticated treatment planning software designed for use in stereotactic radiosurgery. It allows clinicians to plan and simulate the delivery of gamma radiation to specific areas within the brain, optimizing the dose to the target while minimizing exposure to surrounding healthy tissue. The MultiView extension enhances image registration capabilities, aiding in precise treatment planning.
Clinical Applications
This device is commonly used in the treatment of brain tumors, arteriovenous malformations, and functional disorders such as trigeminal neuralgia. It is predominantly utilized in neurosurgical and radiation oncology settings, where precise localization and targeting of lesions are critical. The software is particularly valuable in cases where non-invasive treatment options are preferred, and it is suitable for a wide range of patient populations, including those who are not candidates for traditional surgery.
Indications for Use
The Leksell GammaPlan 4C with MultiView is indicated for planning stereotactic radiosurgery procedures. It is used to treat patients with brain lesions, including tumors and vascular malformations, where precise targeting of radiation is required.
Practical Considerations
Clinicians should ensure compatibility with existing imaging modalities for optimal image registration. The software requires accurate imaging data for precise treatment planning, and users should be familiar with the interface and functionality to maximize its capabilities. Regular updates and training may be necessary to maintain proficiency.
Related Literature
The study titled 'Image registration accuracy of GammaPlan: a phantom study' conducted in 2009 evaluated the accuracy of the automatic image coregistration function in the Leksell GammaPlan software. The study used phantom models to assess the precision of image alignment, which is crucial for accurate treatment planning. The findings highlighted the software's capability to accurately register images, although the study was limited by its use of phantoms rather than clinical data.
Frequently Asked Questions
What is Leksell GammaPlan 4C with MultiView used for?
It is used for planning stereotactic radiosurgery procedures, particularly for targeting brain lesions with gamma radiation.
What specialties typically use this device?
Neurosurgeons and radiation oncologists typically use this device in the treatment of brain tumors and other intracranial conditions.
What are the FDA-cleared indications?
The device is indicated for planning the delivery of gamma radiation to brain lesions, including tumors and vascular malformations, requiring precise targeting.
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.