đź“‹ FDA Reference
plato srs stereotactic radiosurgery planning system model 2 0 plato ifs image fusion software model 2 1
Nucletron
Summary: The PLATO SRS is a stereotactic radiosurgery planning system used for precise targeting in radiation therapy, primarily by radiation oncologists. It aids in planning treatments for lesions in the head and neck region.
FDA Clearance Information
Pathway
510K
Number
K010784 ↗
Decision Date
April 10, 2001
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The PLATO SRS system was cleared through the FDA 510(k) pathway on April 10, 2001, by Nucletron. It is a Class 2 medical device under product code MUJ.
What It Is
The PLATO SRS stereotactic radiosurgery planning system is a software tool designed to assist clinicians in planning precise radiation treatments. It uses advanced imaging fusion techniques to accurately define target volumes and critical structures, enhancing the precision of radiation delivery. This system is particularly useful in treating small, well-defined lesions in sensitive areas such as the brain and neck.
Clinical Applications
This device is commonly used in the field of radiation oncology for planning treatments of cranial and extracranial lesions. It is particularly beneficial in settings where high precision is required, such as treating brain tumors or arteriovenous malformations. The system supports clinicians in hospitals and specialized cancer treatment centers, providing detailed planning capabilities for stereotactic radiosurgery procedures.
Indications for Use
The PLATO SRS system is indicated for use in planning radiation treatments for patients with lesions in the head and neck region. It is suitable for conditions that require precise targeting, such as brain tumors or other complex cranial pathologies.
Practical Considerations
Clinicians should ensure compatibility with existing imaging systems for optimal use. The system requires careful calibration and understanding of stereotactic principles to minimize errors in target localization. Regular updates and training may be necessary to maintain proficiency with the software.
Related Literature
The linked study evaluated the accuracy of positioning and localization materials used with the PLATO-SRS system for treating cervicofacial and encephalic lesions. It found that the initial material tested had a mean error of 5 mm, which was deemed unacceptable. A second material showed improved accuracy with a mean error of 2.5 mm. The study highlights the importance of material selection in minimizing localization errors, though it was limited by its small sample size.
Frequently Asked Questions
What is PLATO SRS used for?
The PLATO SRS is used for planning stereotactic radiosurgery treatments, particularly for lesions in the head and neck region.
What specialties typically use this device?
Radiation oncologists and medical physicists typically use this device in cancer treatment centers.
What are the FDA-cleared indications?
The device is cleared for planning radiation treatments for cranial and extracranial lesions 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.