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imagefusion 2 0
Radionics
Summary: The imagefusion 2 0 by Radionics is a device used in dialysis-access procedures. It is FDA-cleared and supported by studies evaluating its efficacy in prostate imaging.
FDA Clearance Information
Pathway
510K
Number
K990071 ↗
Decision Date
February 8, 1999
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The imagefusion 2 0 was cleared by the FDA via the 510(k) pathway on February 8, 1999. It is manufactured by Radionics and classified as a Class 2 device.
What It Is
The imagefusion 2 0 is a medical device designed for image fusion in clinical settings, particularly for dialysis-access procedures. It integrates imaging modalities to enhance visualization and accuracy.
Clinical Applications
Commonly used in dialysis-access procedures, the device aids in precise imaging, which is crucial for effective treatment planning and execution in clinical settings.
Evidence Summary
The literature includes two studies, ranging from 2004 to 2017, focusing on prostate imaging. These studies are retrospective and prospective in nature.
Reported Outcomes
Published studies report on the device's efficacy in prostate imaging, particularly in assessing prostate volume changes and the influence of prostate-specific antigen density on imaging outcomes.
Safety Profile
Reported complications include no specific adverse events directly linked to the device in the provided studies. Safety data is limited in the available literature.
Evidence Limitations
The evidence is limited to prostate imaging studies, with no direct evaluation of dialysis-access applications. Further research is needed to assess its full clinical utility and safety profile.
Frequently Asked Questions
What are the clinical indications for imagefusion 2 0?
The device is indicated for use in dialysis-access procedures, enhancing imaging accuracy.
What outcomes have been reported in clinical studies?
Studies report on the device's role in prostate imaging, particularly in evaluating prostate volume and PSA density effects.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications directly attributed to the device.
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.