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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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA indications text available in this record is only listed as “Summary” and does not specify a clinical indication.
- The product code and available record should be verified against the original FDA 510(k) summary and labeling before assigning a specific indication.
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.
Practical Considerations
- Verify the original FDA clearance, device description, and labeling before clinical use or categorization.
- Do not assume dialysis-access compatibility, vascular-access functionality, or patient-specific sizing from the existing page text alone.
- Confirm the device’s materials, accessories, sterilization requirements, and compatibility with other equipment in the manufacturer’s instructions for use.
- MRI safety, contraindications, handling requirements, and expected service life are not established by the information provided.
- The device was cleared as a Class II device under 510(k) K982791 on December 30, 1998; later labeling or product changes may not be reflected here.
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.