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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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA indications text supplied for this record is only “Summary” and does not state a specific intended use.
- The product code and device name alone are insufficient to establish a dialysis-access indication.
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.
Practical Considerations
- Confirm the exact device identity, model designation, and manufacturer because the supplied name and manufacturer entry may be truncated or misspelled.
- Review the original FDA 510(k) summary, labeling, user manual, and any applicable accessories before describing clinical applications.
- Do not assume compatibility with dialysis equipment, imaging systems, or other procedure-room devices without manufacturer documentation.
- MRI safety, operating limitations, calibration requirements, contraindications, and service life are not established by the information supplied here.
- The FDA record indicates a Class II 510(k) clearance dated 2006 under product code MUJ; clearance does not by itself define every clinical use or confirm current availability.
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.