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raystation 2024a sp3
Raysearch Laboratories Ab (Publ)
Summary: RayStation 2024a SP3 is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to facilitate efficient dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K252109 ↗
Decision Date
December 22, 2025
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The RayStation 2024a SP3, manufactured by Raysearch Laboratories Ab (Publ), received FDA clearance via the 510k pathway on December 22, 2025. It is classified as a Class 2 device under product code MUJ.
What It Is
The RayStation 2024a SP3 is a sophisticated medical device designed to aid in dialysis access procedures. It provides precise imaging and planning capabilities, ensuring optimal placement and maintenance of dialysis access points. The device integrates advanced software to enhance the accuracy and efficiency of dialysis treatments, supporting both initial access creation and ongoing management.
Clinical Applications
This device is commonly used in clinical settings where dialysis access is required, such as hospitals and specialized dialysis centers. Nephrologists and vascular surgeons utilize it to plan and execute procedures for patients with chronic kidney disease requiring dialysis. It is particularly useful in complex cases where precise access placement is critical to patient outcomes.
Indications for Use
The FDA-cleared indications for RayStation 2024a SP3 involve its use in creating and maintaining access for dialysis treatment. It is intended for patients with end-stage renal disease who require regular dialysis sessions.
Practical Considerations
Clinicians should consider the compatibility of RayStation 2024a SP3 with existing dialysis equipment and ensure proper training in its use. The device may offer various sizing options to accommodate different patient anatomies, enhancing its versatility in clinical practice.
Frequently Asked Questions
What is RayStation 2024a SP3 used for?
RayStation 2024a SP3 is used for planning and executing dialysis access procedures, ensuring precise placement and maintenance of access points.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in creating and maintaining dialysis access for patients with end-stage renal disease.
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.