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syngo via rt image suite
Siemens Medical Solutions U
Summary: The syngo via rt image suite is a medical imaging software used primarily for analyzing and processing radiological images, particularly in the context of dialysis-access devices. It is utilized by radiologists and clinicians in hospital and outpatient settings.
FDA Clearance Information
Pathway
510K
Number
K173635 ↗
Decision Date
January 12, 2018
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 January 12, 2018. It is manufactured by Siemens Medical Solutions U and classified as a Class 2 device under product code MUJ.
What It Is
The syngo via rt image suite is an advanced imaging software platform designed to enhance the analysis and interpretation of radiological images. It supports various imaging modalities and offers tools for semi-automatic and automatic volumetric analysis. This software is particularly useful in settings requiring detailed image segmentation and volumetric assessments, such as in the evaluation of pulmonary nodules or other complex anatomical structures.
Clinical Applications
This device is commonly used in radiology departments for the assessment of dialysis-access devices and other vascular structures. It aids in the planning and evaluation of interventions by providing detailed imaging insights. The software is particularly beneficial in oncology for the segmentation and volumetric analysis of tumors, and in pulmonology for assessing pulmonary nodules.
Indications for Use
The FDA indications suggest that this software is intended for use in the analysis of images related to dialysis-access devices. It is suitable for patients requiring detailed imaging studies, particularly those with conditions affecting vascular access or pulmonary health.
Practical Considerations
The syngo via rt image suite is compatible with various imaging modalities, including CT and MRI. It offers flexible tools for image segmentation, which can be tailored to the specific needs of the clinical scenario. Clinicians should ensure compatibility with existing imaging systems and consider training for optimal use of its advanced features.
Related Literature
The linked study examined the precision of different volumetry tools for segmenting pulmonary nodules in a chest CT phantom model. It compared manual, semi-automatic, and automatic contouring methods, including a deep-learning algorithm. The study found variability in gross tumor volume measurements across methods, highlighting the importance of selecting appropriate tools for specific clinical needs. Limitations include the use of a phantom model, which may not fully replicate in vivo conditions.
Frequently Asked Questions
What is syngo via rt image suite used for?
It is used for analyzing and processing radiological images, particularly in the context of dialysis-access devices and other complex anatomical assessments.
What specialties typically use this device?
Radiology, oncology, and pulmonology specialties commonly use this device for detailed image analysis and volumetric assessments.
What are the FDA-cleared indications?
The device is indicated for use in the analysis of images related to dialysis-access devices, aiding in the evaluation and planning of interventions.
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.