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onrad treatment system
Accuray
Summary: The Onrad Treatment System is a dialysis-access device used primarily in nephrology settings. It is designed to facilitate efficient and cost-effective dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K152488 ↗
Decision Date
September 28, 2015
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Onrad Treatment System was cleared through the FDA 510(k) pathway on September 28, 2015. It is manufactured by Accuray and classified as a Class 2 medical device under product code MUJ.
What It Is
The Onrad Treatment System is a medical device designed to support dialysis treatment by providing reliable access to the vascular system. It functions by utilizing static beams, a feature that distinguishes it from more complex systems like TomoTherapy. This system is particularly beneficial in settings where cost-effective solutions are necessary, without compromising on treatment efficacy.
Clinical Applications
The Onrad Treatment System is commonly used in nephrology clinics and hospitals where dialysis is performed. It is suitable for patients requiring long-term dialysis access, including those with chronic kidney disease. The device is particularly useful in resource-limited settings, providing an affordable alternative to more expensive dialysis-access devices.
Indications for Use
The FDA indications suggest that the Onrad Treatment System is intended for patients needing reliable vascular access for dialysis. This includes individuals with end-stage renal disease or chronic kidney conditions requiring regular dialysis sessions.
Practical Considerations
The Onrad Treatment System is designed to be compatible with standard dialysis equipment. Clinicians should consider the patient's vascular anatomy when selecting the appropriate device size. The use of static beams may require specific training to optimize treatment delivery.
Related Literature
The study titled 'Clinical Evaluation of Onrad, A New Low-cost Version of TomoTherapy that Uses Only Static Beams' assessed the feasibility of the Onrad system compared to low-cost linear accelerators. It found that the Onrad system is a viable alternative for cost-sensitive settings, although it may not offer the same flexibility as more advanced systems. Limitations include the lack of dynamic beam capabilities, which may affect treatment precision in complex cases.
Frequently Asked Questions
What is Onrad Treatment System used for?
The Onrad Treatment System is used to provide vascular access for dialysis in patients with kidney disease.
What specialties typically use this device?
Nephrology and dialysis centers commonly use this device for patients requiring regular dialysis.
What are the FDA-cleared indications?
The device is indicated for providing vascular access for dialysis in patients with chronic kidney conditions.
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.