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syngo via rt image suite
Siemens Medical Solutions U
Summary: The syngo via rt image suite is a software solution used for imaging in dialysis-access procedures. It is primarily used by radiologists and clinicians in medical imaging departments.
FDA Clearance Information
Pathway
510K
Number
K192065 ↗
Decision Date
September 18, 2019
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The syngo via rt image suite was cleared through the FDA 510(k) pathway on September 18, 2019. It is manufactured by Siemens Medical Solutions U and is classified as a Class 2 device under product code MUJ.
What It Is
The syngo via rt image suite is a sophisticated imaging software designed to enhance the visualization and analysis of medical images, particularly in the context of dialysis-access devices. It integrates various imaging modalities to provide comprehensive image processing and analysis capabilities. This suite is particularly useful for clinicians who require precise imaging for planning and evaluating dialysis access procedures.
Clinical Applications
This device is commonly used in radiology and interventional radiology settings, especially for patients requiring dialysis. It aids in the accurate visualization of vascular structures, which is crucial for planning and monitoring dialysis access. The software is used by radiologists, nephrologists, and vascular surgeons who specialize in managing patients with chronic kidney disease.
Indications for Use
The syngo via rt image suite is indicated for use in imaging related to dialysis-access devices. It is designed to assist in the planning and evaluation of vascular access in patients undergoing dialysis, ensuring optimal placement and function of access devices.
Practical Considerations
The software is compatible with various imaging modalities, including CT and MRI. Clinicians should ensure that the imaging suite is integrated with their existing systems for seamless operation. Familiarity with the software's interface and functions is essential for optimal use.
Related Literature
The linked study examined the precision of various volumetry tools for segmenting pulmonary nodules in a chest CT phantom. It compared manual, semi-automatic, and automatic methods, including a deep-learning algorithm. The study found differences in precision among the methods, highlighting the potential of automated tools for improving accuracy. However, the study was limited to a phantom model, and further research is needed in clinical settings.
Frequently Asked Questions
What is syngo via rt image suite used for?
It is used for imaging and analysis in dialysis-access procedures, helping clinicians visualize and plan vascular access.
What specialties typically use this device?
Radiologists, nephrologists, and vascular surgeons commonly use this device in medical imaging and interventional radiology settings.
What are the FDA-cleared indications?
The device is indicated for imaging related to dialysis-access devices, assisting in the planning and evaluation of vascular access for dialysis patients.
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.