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clearcalc model radca v2 6
Radformation
Summary: The ClearCalc Model RadCa V2 6 is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and radiologists to assist in the accurate placement and maintenance of dialysis access devices.
FDA Clearance Information
Pathway
510K
Number
K252863 ↗
Decision Date
December 19, 2025
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The ClearCalc Model RadCa V2 6 was cleared through the FDA 510(k) pathway on December 19, 2025. It is manufactured by Radformation and is classified as a Class 2 device under product code MUJ.
What It Is
The ClearCalc Model RadCa V2 6 is a specialized device designed to aid in dialysis access procedures. It utilizes advanced imaging and calculation algorithms to enhance the precision of catheter placement and maintenance. This device is particularly useful in ensuring optimal blood flow and reducing complications associated with dialysis access.
Clinical Applications
This device is commonly used in clinical settings where dialysis access is required, such as hospitals and specialized nephrology clinics. It is particularly beneficial for patients with chronic kidney disease who require regular dialysis. Nephrologists and interventional radiologists often use this device to ensure accurate placement of dialysis catheters, which is crucial for effective treatment.
Indications for Use
The FDA indications for the ClearCalc Model RadCa V2 6 involve its use in procedures related to dialysis access. This includes assisting in the placement and maintenance of catheters for patients undergoing dialysis, ensuring proper function and reducing the risk of complications.
Practical Considerations
The device is compatible with standard dialysis catheters and is designed to integrate seamlessly into existing dialysis workflows. Clinicians should be familiar with its imaging capabilities and calculation functions to maximize its benefits. Proper training is recommended to ensure optimal use.
Frequently Asked Questions
What is ClearCalc Model RadCa V2 6 used for?
It is used to assist in the accurate placement and maintenance of dialysis access devices, such as catheters.
What specialties typically use this device?
Nephrologists and interventional radiologists are the primary users of this device.
What are the FDA-cleared indications?
It is indicated for use in dialysis access procedures, specifically for the placement and maintenance of dialysis catheters.
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.