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medcom rt-viewer system
Medcom
Summary: The Medcom RT-Viewer System is a medical device used for visualizing dialysis access devices. It is primarily used by nephrologists and vascular surgeons to ensure proper placement and function of dialysis access points.
FDA Clearance Information
Pathway
510K
Number
K100056 ↗
Decision Date
May 7, 2010
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Medcom RT-Viewer System was cleared by the FDA via the 510(k) pathway on May 7, 2010. It is manufactured by Medcom and classified as a Class 2 device under product code MUJ.
What It Is
The Medcom RT-Viewer System is a specialized imaging device designed to assist in the visualization of dialysis access devices. It provides real-time imaging capabilities that help clinicians assess and ensure the proper placement and functionality of dialysis access points. This system is particularly useful in monitoring the condition of arteriovenous fistulas and grafts, which are critical for effective dialysis treatment.
Clinical Applications
This device is commonly used in nephrology and vascular surgery settings. It is essential for procedures involving the creation, maintenance, and monitoring of dialysis access points, such as arteriovenous fistulas and grafts. The system is used in hospitals and dialysis centers, primarily serving patients with end-stage renal disease who require regular dialysis.
Indications for Use
The FDA-cleared indications for the Medcom RT-Viewer System focus on its use in visualizing dialysis access devices. It is intended for patients who need dialysis, helping clinicians ensure that access points are properly placed and functioning effectively.
Practical Considerations
The Medcom RT-Viewer System is compatible with standard dialysis access devices and requires minimal setup. Clinicians should be familiar with imaging techniques to maximize the device's utility. Regular calibration and maintenance are recommended to ensure optimal performance.
Frequently Asked Questions
What is the Medcom RT-Viewer System used for?
It is used for visualizing and assessing the placement and function of dialysis access devices.
What specialties typically use this device?
Nephrologists and vascular surgeons commonly use this device in their practice.
What are the FDA-cleared indications?
The device is indicated for use in visualizing dialysis access devices to ensure proper placement and function.
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.