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coherence dosimetrist model 2 2
Siemens Medical Solutions U
Summary: The Coherence Dosimetrist Model 2 2 is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to ensure accurate dosimetry during treatment.
FDA Clearance Information
Pathway
510K
Number
K061097 ↗
Decision Date
June 7, 2006
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Coherence Dosimetrist Model 2 2 was cleared through the FDA 510k pathway on June 7, 2006. Manufactured by Siemens Medical Solutions U, it is classified as a Class 2 device under product code MUJ.
What It Is
The Coherence Dosimetrist Model 2 2 is a specialized device designed to assist in the precise measurement and delivery of dosimetry during dialysis access procedures. It leverages advanced technology to ensure accurate dosing, which is critical for patient safety and treatment efficacy. This device is part of a suite of tools used to optimize dialysis access, ensuring that patients receive the correct amount of treatment in a controlled manner.
Clinical Applications
This device is commonly used in clinical settings where dialysis access is performed, such as hospitals and specialized dialysis centers. Nephrologists and vascular surgeons use it to ensure accurate dosimetry during procedures like arteriovenous fistula creation or maintenance. It is particularly beneficial for patients with chronic kidney disease requiring regular dialysis, as it helps maintain the integrity and functionality of their access points.
Indications for Use
The FDA indications for the Coherence Dosimetrist Model 2 2 suggest its use in procedures related to dialysis access. It is intended for patients who require precise dosimetry to ensure effective and safe dialysis treatment, typically those with end-stage renal disease.
Practical Considerations
When using the Coherence Dosimetrist Model 2 2, clinicians should be aware of its compatibility with existing dialysis equipment. It is important to follow manufacturer guidelines for setup and calibration to ensure accurate measurements. The device may come in various sizes to accommodate different clinical needs and patient anatomies.
Frequently Asked Questions
What is Coherence Dosimetrist Model 2 2 used for?
It is used for precise dosimetry in dialysis access procedures to ensure accurate treatment delivery.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in dialysis access procedures to ensure precise dosimetry, primarily for patients with chronic kidney disease.
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.