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syngo vsim
Siemens Medical Solutions U
Summary: The syngo vsim is a medical device used for planning and simulating vascular access procedures, primarily in dialysis patients. It is used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K151887 ↗
Decision Date
September 16, 2015
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The syngo vsim by Siemens Medical Solutions U received FDA clearance via the 510(k) pathway on September 16, 2015. It is classified as a Class 2 device under product code MUJ.
What It Is
The syngo vsim is a software-based medical device designed to assist in the planning and simulation of vascular access procedures. It provides clinicians with a virtual environment to simulate various scenarios, enhancing pre-procedural planning and decision-making. This tool is particularly useful in complex cases where precise vascular access is critical.
Clinical Applications
The syngo vsim is commonly used in the context of dialysis access procedures, where accurate placement of catheters is crucial. It is utilized in interventional radiology suites and vascular surgery settings, aiding in the visualization and planning of access routes. The device is particularly beneficial for patients with challenging vascular anatomies, such as those with previous access failures or complex vascular conditions.
Indications for Use
The FDA-cleared indications for syngo vsim involve its use in planning and simulating dialysis access procedures. It is intended for patients who require vascular access for dialysis, helping clinicians optimize the approach and technique.
Practical Considerations
Clinicians should ensure compatibility with existing imaging systems and be familiar with the software interface for optimal use. The device may require specific training to fully leverage its simulation capabilities. It is important to consider patient-specific anatomical variations during simulation.
Frequently Asked Questions
What is syngo vsim used for?
Syngo vsim is used for planning and simulating vascular access procedures, particularly for dialysis patients.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use syngo vsim.
What are the FDA-cleared indications?
The device is indicated for planning and simulating dialysis access procedures, aiding in the selection of optimal vascular access routes.
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.