📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Planning stereotactic radiosurgery treatments for lesions in the head and neck region.
- Using image-fusion software to support localization and treatment planning for radiation therapy.
- Assisting clinicians in defining target volumes and relevant anatomical structures during stereotactic treatment planning.
Clinical Applications
- Planning stereotactic radiation treatment for selected intracranial lesions.
- Planning radiation treatment for lesions in other parts of the head and neck.
- Fusing or registering medical images to support target localization.
- Delineating treatment targets and nearby critical structures before radiation delivery.
Practical Considerations
- This is a treatment-planning software system, not a radiation-delivery device; treatment is delivered by compatible radiation equipment.
- Compatibility with the facility's imaging modalities, image formats, treatment-planning workflow, and radiation-delivery system should be confirmed before use.
- Accurate image registration, patient immobilization, contouring, and stereotactic quality assurance are essential to reduce targeting errors.
- MRI and other imaging data may be used only when supported by the system and the facility's validated workflow; MRI safety applies to the scanner and accessories, not automatically to the planning software.
- The record identifies a Class II device cleared through the 510(k) pathway under product code MUJ; current software support, validation, and cybersecurity status should be confirmed with the manufacturer or facility.
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.