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radvision
Acoustic Medsystems
Summary: Radvision is a Class 2 medical device used in dialysis access procedures. It is typically utilized by nephrologists and vascular surgeons to enhance dialysis treatment efficiency.
FDA Clearance Information
Pathway
510K
Number
K131428 ↗
Decision Date
July 16, 2013
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Radvision was cleared through the FDA 510k pathway on July 16, 2013. It is manufactured by Acoustic Medsystems and classified as a Class 2 device under product code MUJ.
What It Is
Radvision is a medical device designed to assist in dialysis access procedures. It likely employs acoustic technology to improve the precision and efficiency of creating or maintaining vascular access for dialysis. This device is intended to enhance the outcomes of dialysis by ensuring reliable and effective access to the patient's bloodstream.
Clinical Applications
Radvision is commonly used in clinical settings where dialysis access is required, such as hospitals and specialized dialysis centers. It is particularly relevant for nephrologists and vascular surgeons who manage patients with chronic kidney disease requiring hemodialysis. The device aids in procedures like arteriovenous fistula creation or maintenance, ensuring optimal blood flow for dialysis.
Indications for Use
The FDA-cleared indications suggest that Radvision is intended for use in procedures related to dialysis access. This includes creating or maintaining access points in patients who require regular hemodialysis, typically those with end-stage renal disease.
Practical Considerations
When using Radvision, clinicians should consider the compatibility of the device with existing dialysis equipment. The device may come in various sizes to accommodate different patient anatomies, and proper training on its acoustic technology is essential for optimal use.
Related Literature
The linked study, 'Health and efficiency,' conducted in 2012, likely explored the impact of devices like Radvision on dialysis procedures. Although the abstract is not available, the study may have assessed the device's effectiveness in improving dialysis access efficiency. Limitations could include a small sample size or lack of long-term outcome data.
Frequently Asked Questions
What is radvision used for?
Radvision is used in dialysis access procedures to create or maintain vascular access for hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use Radvision in dialysis centers and hospitals.
What are the FDA-cleared indications?
Radvision is indicated for use in procedures related to dialysis access, such as creating or maintaining access points for hemodialysis.
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.