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sensus tps workstation
Sensus Healthcare
Summary: The Sensus TPS Workstation by Sensus Healthcare is a Class 2 medical device used in dialysis-access procedures. It is primarily utilized by nephrologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K182665 ↗
Decision Date
February 21, 2019
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Sensus TPS Workstation was cleared through the FDA 510k pathway on February 21, 2019. Manufactured by Sensus Healthcare, it is classified as a Class 2 device under product code MUJ.
What It Is
The Sensus TPS Workstation is a specialized medical device designed to assist in dialysis-access procedures. It provides precise targeting and planning capabilities, enhancing the accuracy of vascular access creation. This device is crucial in ensuring effective and efficient dialysis treatment by improving the quality of access sites.
Clinical Applications
Commonly used in nephrology and vascular surgery settings, the Sensus TPS Workstation aids in the planning and execution of dialysis-access procedures. It is particularly beneficial in hospital and outpatient clinic environments where dialysis is performed. The device is used for patients requiring long-term dialysis, ensuring reliable and durable vascular access.
Indications for Use
The FDA-cleared indications for the Sensus TPS Workstation involve its use in creating and maintaining vascular access for dialysis patients. It is intended for patients who require dialysis due to kidney failure or chronic kidney disease.
Practical Considerations
The Sensus TPS Workstation is compatible with standard dialysis-access equipment and can be integrated into existing clinical workflows. Clinicians should be trained in its operation to maximize its benefits in improving access site outcomes.
Frequently Asked Questions
What is the Sensus TPS Workstation used for?
The Sensus TPS Workstation is used for planning and executing dialysis-access procedures, ensuring precise and effective vascular access.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in settings where dialysis is performed.
What are the FDA-cleared indications?
The device is indicated for use in creating and maintaining vascular access for patients requiring dialysis.
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.