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xbeam v2
Xstrahl
Summary: The xbeam v2 by Xstrahl is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to ensure effective dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K240671 ↗
Decision Date
December 4, 2024
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The xbeam v2 was cleared through the FDA 510k pathway on December 4, 2024. Manufactured by Xstrahl, it is classified as a Class 2 device under product code MUJ.
What It Is
The xbeam v2 is a specialized device designed to assist in dialysis access procedures. It provides precise imaging and treatment capabilities to facilitate the creation and maintenance of vascular access points. This device is crucial for ensuring that patients undergoing dialysis have reliable and functional access sites, which are essential for effective treatment.
Clinical Applications
The xbeam v2 is commonly used in clinical settings where dialysis access is required, such as hospitals and specialized dialysis centers. Nephrologists and vascular surgeons use this device to create and maintain arteriovenous fistulas or grafts in patients with renal failure. It is particularly beneficial in scenarios where imaging and precision are critical to the success of the procedure.
Indications for Use
The FDA-cleared indications for the xbeam v2 involve its use in procedures related to dialysis access. This includes the creation and maintenance of vascular access points necessary for patients undergoing dialysis treatment.
Practical Considerations
The xbeam v2 is compatible with standard dialysis access equipment and comes in various sizes to accommodate different patient anatomies. Clinicians should be familiar with its imaging capabilities to optimize procedural outcomes. Proper technique and training are essential for maximizing the device's effectiveness.
Frequently Asked Questions
What is xbeam v2 used for?
The xbeam v2 is used for creating and maintaining vascular access in dialysis patients.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use the xbeam v2.
What are the FDA-cleared indications?
The device is indicated for use in dialysis access procedures, including the creation and maintenance of vascular access points.
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.