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clearcalc model radca v2
Radformation
Summary: The ClearCalc Model RadCa V2 is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to ensure precise calculations during dialysis access planning.
FDA Clearance Information
Pathway
510K
Number
K220582 ↗
Decision Date
August 22, 2022
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The ClearCalc Model RadCa V2 was cleared through the FDA's 510(k) pathway on August 22, 2022. Manufactured by Radformation, it is classified as a Class 2 device under product code MUJ.
What It Is
The ClearCalc Model RadCa V2 is a software tool designed to assist clinicians in planning dialysis access procedures. It provides accurate calculations and assessments to optimize vascular access, crucial for effective dialysis treatment. The device integrates with existing imaging systems to enhance precision in planning and execution.
Clinical Applications
This device is commonly used in nephrology and vascular surgery settings, particularly in hospitals and specialized dialysis centers. It assists in pre-procedural planning for patients requiring dialysis, ensuring optimal placement and function of access devices. It is particularly beneficial for patients with complex vascular anatomy or those requiring repeated access procedures.
Indications for Use
The ClearCalc Model RadCa V2 is indicated for use in patients requiring dialysis access. It aids in the planning and assessment of vascular access sites, ensuring effective and safe dialysis treatment.
Practical Considerations
The device is compatible with standard imaging systems used in vascular procedures. Clinicians should ensure proper integration with existing equipment for optimal performance. Familiarity with the software interface and calculation parameters is recommended for efficient use.
Frequently Asked Questions
What is ClearCalc Model RadCa V2 used for?
It is used for planning and assessing dialysis access procedures to ensure optimal vascular access.
What specialties typically use this device?
Nephrologists and vascular surgeons commonly use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in planning dialysis access procedures, aiding in the assessment of vascular access sites.
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.