đź“‹ FDA Reference
rocs tps
Radiation Oncology Computer Systems
Summary: The rocs tps is a medical device used in dialysis access procedures. It is utilized by clinicians specializing in nephrology and vascular surgery to facilitate efficient dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K982791 ↗
Decision Date
December 30, 1998
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The rocs tps was cleared through the FDA 510(k) pathway on December 30, 1998. Manufactured by Radiation Oncology Computer Systems, it is classified as a Class 2 device under product code MUJ.
What It Is
The rocs tps is a medical device designed to assist in dialysis access procedures. It functions by providing precise targeting and placement capabilities for vascular access, which is crucial for effective dialysis treatment. The device is engineered to enhance the accuracy and efficiency of creating and maintaining access points in patients requiring dialysis.
Clinical Applications
The rocs tps is commonly used in clinical settings such as hospitals and dialysis centers. It is particularly relevant in nephrology and vascular surgery specialties, where it aids in the creation and maintenance of arteriovenous fistulas or grafts. This device is essential for patients with chronic kidney disease who require regular dialysis, ensuring reliable vascular access.
Indications for Use
The FDA-cleared indications for the rocs tps involve its use in procedures related to dialysis access. This means it is intended for patients who need vascular access for dialysis treatment, typically those with end-stage renal disease.
Practical Considerations
When using the rocs tps, clinicians should consider the compatibility with existing dialysis equipment and the specific anatomical requirements of the patient. The device is typically available in various sizes to accommodate different patient needs and ensure optimal access placement.
Frequently Asked Questions
What is rocs tps used for?
The rocs tps is used for creating and maintaining vascular access in dialysis patients.
What specialties typically use this device?
Nephrology and vascular surgery specialties typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in dialysis access procedures for patients requiring vascular access.
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.