📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA-cleared indication is not provided in the supplied record.
- The product code MUJ and the available device name do not support a dialysis-access indication.
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.
Practical Considerations
- Confirm the complete FDA 510(k) summary and labeling before describing specific clinical indications or treatment functions.
- This is software rather than an implanted or catheter-based device, so physical device size, vessel compatibility and implant duration do not apply.
- Use requires validated installation, appropriate user training and compatibility with the institution's radiation therapy equipment and information systems.
- MRI safety depends on the MRI scanner, imaging workflow and any connected hardware; the software itself should not be described as an MRI device without labeling support.
- Clinical use should follow the manufacturer's instructions, institutional quality assurance procedures and applicable radiation safety requirements.
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.