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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 for advanced visualization and analysis, primarily in radiology and oncology settings. It assists clinicians in evaluating complex imaging data, enhancing diagnostic accuracy and treatment planning.
FDA Clearance Information
Pathway
510K
Number
K162370 ↗
Decision Date
October 25, 2016
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 October 25, 2016. Manufactured by Siemens Medical Solutions U, it is 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 facilitate the visualization, analysis, and interpretation of medical images. It integrates with existing imaging modalities to provide enhanced tools for volumetric analysis, segmentation, and contouring, which are crucial in the assessment and treatment planning of various conditions, including cancer. The software supports semi-automatic and automatic processing, improving workflow efficiency and accuracy.
Clinical Applications
This device is commonly used in radiology and oncology departments for the evaluation of complex imaging data such as CT and MRI scans. It is particularly useful in the planning and monitoring of cancer treatments, where precise volumetric analysis of tumors is critical. The software aids in the segmentation of anatomical structures, making it valuable in both diagnostic and therapeutic settings, including surgical planning and radiation therapy.
Indications for Use
The syngo via rt image suite is indicated for use in the analysis and interpretation of medical images, particularly in the context of oncology for tumor evaluation and treatment planning. It is suitable for patients requiring detailed imaging assessments, such as those with cancer or other conditions requiring precise anatomical visualization.
Practical Considerations
The software is compatible with a range of imaging modalities and integrates seamlessly into existing hospital IT infrastructures. It requires appropriate hardware specifications to run efficiently, and users should be trained in its advanced features to maximize its clinical utility. Consideration should be given to the compatibility with existing PACS systems and the need for regular software updates.
Related Literature
The linked study examined the precision of various volumetry tools, including semi-automatic and automatic methods, for segmenting pulmonary nodules in a chest CT phantom model. The study found that different contouring approaches, including a deep-learning algorithm, provided varying levels of accuracy in measuring gross tumor volumes. While the study highlights the potential of automated tools in improving segmentation accuracy, it also notes limitations in intermodality comparisons and the need for further validation in clinical settings.
Frequently Asked Questions
What is syngo via rt image suite used for?
It is used for advanced visualization and analysis of medical images, particularly in radiology and oncology for tumor evaluation and treatment planning.
What specialties typically use this device?
Radiology and oncology specialists commonly use this device for imaging analysis and treatment planning.
What are the FDA-cleared indications?
The device is indicated for the analysis and interpretation of medical images, especially for evaluating tumors and planning treatments in oncology.
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.