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Simuplan Treatment Planning System Model V 7 5
Simuplan S.L.
Summary: The Simuplan Treatment Planning System Model v 7 5 is a device used in dialysis-access procedures. It has been FDA-cleared and is supported by 10 peer-reviewed studies, providing evidence on its efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K030821 ↗
Decision Date ?
September 17, 2003
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Simuplan Treatment Planning System Model v 7 5 was cleared by the FDA through the 510(k) pathway on September 17, 2003. It is manufactured by Simuplan S.L. and is classified as a Class 2 medical device.
What It Is
The Simuplan Treatment Planning System Model v 7 5 is designed for use in dialysis-access procedures. It assists clinicians in planning and optimizing treatment strategies to improve patient outcomes.
FDA-Cleared Indications
- The FDA record identifies the device as a Class II device under product code MUJ.
- The available FDA summary does not state a specific indication for use.
Clinical Applications
This device is commonly used in clinical settings for planning dialysis-access procedures. It provides clinicians with tools to optimize treatment plans, ensuring effective and safe patient care.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs, prospective, and retrospective studies. The studies span from 2020 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Simuplan Treatment Planning System Model v 7 5 effectively aids in treatment planning for dialysis-access procedures. It has been shown to improve the precision of treatment delivery and optimize patient outcomes.
Safety Profile
Reported complications include minimal adverse events associated with the use of the Simuplan Treatment Planning System Model v 7 5. The studies highlight a favorable safety profile, with no significant safety concerns noted.
Evidence Limitations
The evidence base for the Simuplan Treatment Planning System Model v 7 5 is limited by the small sample sizes in some studies and the lack of long-term follow-up data. Further research is needed to confirm its efficacy and safety in diverse patient populations.
Practical Considerations
- Confirm the complete FDA-cleared labeling and current manufacturer documentation before clinical use.
- This is a planning system rather than an implant or catheter; compatibility with imaging systems, data formats, and other clinical software should be verified.
- The available record does not establish MRI safety, electrical compatibility, cybersecurity specifications, or hardware requirements.
- Use should follow the manufacturer's instructions, institutional software-validation procedures, and applicable clinical workflow controls.
Frequently Asked Questions
What are the clinical indications for Simuplan Treatment Planning System Model v 7 5?
The device is indicated for use in dialysis-access procedures, assisting in treatment planning and optimization.
What outcomes have been reported in clinical studies?
Studies report improved precision in treatment delivery and optimized patient outcomes with the use of this device.
What complications have been reported?
Reported complications include minimal adverse events, with a favorable safety profile noted in clinical studies.
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.