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raycare 2024a sp1
Raysearch Laboratories Ab (Publ)
Summary: RayCare 2024a SP1 is a dialysis-access device used primarily in nephrology settings for patients requiring dialysis. It is designed to facilitate efficient and safe access for dialysis treatments.
FDA Clearance Information
Pathway
510K
Number
K242992 ↗
Decision Date
April 17, 2025
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RayCare 2024a SP1 was cleared via the FDA 510k pathway on April 17, 2025. Manufactured by Raysearch Laboratories Ab, it is classified as a Class 2 device under product code MUJ.
What It Is
RayCare 2024a SP1 is a medical device designed to provide vascular access for patients undergoing dialysis. It is engineered to ensure reliable and efficient blood flow during dialysis sessions. The device likely incorporates advanced materials and design features to minimize complications such as infection or thrombosis, common concerns in dialysis access.
Clinical Applications
This device is primarily used in nephrology departments and dialysis centers. It is suitable for patients with chronic kidney disease requiring regular dialysis. The device is used by nephrologists and dialysis nurses to provide stable and long-term vascular access, crucial for effective dialysis treatment.
Indications for Use
The FDA indications suggest that RayCare 2024a SP1 is intended for patients who need dialysis access. It is suitable for those with compromised kidney function who require regular dialysis sessions to manage their condition.
Practical Considerations
Clinicians should consider the compatibility of RayCare 2024a SP1 with existing dialysis equipment. Proper sizing and placement technique are critical to ensure optimal performance and patient comfort. Training on device handling and maintenance may be necessary to prevent complications.
Related Literature
The linked study explores an open-source framework for pre-clinical ion-beam research, focusing on radiation effects in particle therapy. It highlights the need for standardized data processing in multi-vendor settings. While not directly related to RayCare 2024a SP1, the study underscores the importance of robust data handling in clinical research. Limitations include its pre-clinical focus and potential variability across different research environments.
Frequently Asked Questions
What is RayCare 2024a SP1 used for?
RayCare 2024a SP1 is used to provide vascular access for patients undergoing dialysis.
What specialties typically use this device?
Nephrology and dialysis centers commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring dialysis access, particularly those with chronic kidney 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.