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simuplan treatment planning system
Simuplan S.L.
Summary: The Simuplan Treatment Planning System is used in dialysis-access devices. It is FDA 510k cleared and supported by 10 studies, focusing on treatment planning accuracy and safety.
FDA Clearance Information
Pathway
510K
Number
K120551 ↗
Decision Date
June 8, 2012
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Simuplan Treatment Planning System was cleared through the FDA 510k pathway on June 8, 2012. It is manufactured by Simuplan S.L. and classified as a Class 2 device.
What It Is
The Simuplan Treatment Planning System is a software tool designed to assist clinicians in planning treatments for dialysis-access devices. It automates the creation of treatment plans based on patient-specific data.
Clinical Applications
This device is commonly used in clinical scenarios involving dialysis-access procedures, where precise treatment planning is critical to ensure effective and safe patient outcomes.
Evidence Summary
The available literature includes 10 studies, ranging from 2022 to 2023, encompassing various study types such as RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report that the Simuplan Treatment Planning System enhances the accuracy of treatment plans in radiation therapy and other clinical applications. It has been shown to improve the precision of radiation delivery and optimize treatment efficacy.
Safety Profile
Reported complications include potential inaccuracies in treatment planning if the system is not used correctly. However, no significant adverse events have been directly attributed to the device in the studies reviewed.
Evidence Limitations
The evidence base is limited by the small number of studies specifically focused on the Simuplan system. Further research is needed to explore long-term outcomes and comparative effectiveness against other planning systems.
Frequently Asked Questions
What are the clinical indications for Simuplan Treatment Planning System?
The device is indicated for use in planning treatments for dialysis-access devices, ensuring precise and effective treatment delivery.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy and efficacy in treatment planning, particularly in radiation therapy applications.
What complications have been reported?
Safety data indicate potential planning inaccuracies if the system is not used properly, but no significant adverse events have been reported.
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.