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siemens virtual simulation vsim
Siemens Medical Solutions U
Summary: The Siemens Virtual Simulation vSim is a medical device used in the planning and simulation of dialysis access procedures. It is primarily utilized by nephrologists and interventional radiologists to enhance precision and outcomes.
FDA Clearance Information
Pathway
510K
Number
K022036 ↗
Decision Date
November 5, 2002
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Siemens Virtual Simulation vSim received FDA clearance through the 510k pathway on November 5, 2002. It is manufactured by Siemens Medical Solutions U and is classified as a Class 2 device under product code MUJ.
What It Is
The Siemens Virtual Simulation vSim is a software-based medical device designed to aid in the virtual simulation of dialysis access procedures. It allows clinicians to visualize and plan interventions with enhanced accuracy, reducing the risk of complications. By simulating the procedure in a virtual environment, clinicians can assess anatomical variations and optimize the approach before actual intervention.
Clinical Applications
This device is commonly used in nephrology and interventional radiology settings, particularly for patients requiring dialysis access. It assists in pre-procedural planning for arteriovenous fistulas or grafts, ensuring optimal placement and function. The vSim is beneficial in both hospital and outpatient settings, catering to adult and geriatric populations undergoing dialysis.
Indications for Use
The Siemens Virtual Simulation vSim is indicated for use in planning dialysis access procedures. It is particularly useful for patients requiring precise vascular access, such as those with complex anatomy or previous access failures.
Practical Considerations
Clinicians should ensure compatibility with existing imaging systems and software. Familiarity with virtual simulation technology is beneficial for optimal use. The device may require specific training to fully leverage its capabilities in clinical practice.
Frequently Asked Questions
What is Siemens Virtual Simulation vSim used for?
It is used for planning and simulating dialysis access procedures to improve accuracy and outcomes.
What specialties typically use this device?
Nephrologists and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for planning dialysis access procedures, particularly for patients needing precise vascular access.
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.