đź“‹ FDA Reference
syngo via rt image suite
Siemens Medical Solutions U
Summary: The syngo via rt image suite is a medical imaging software used primarily for the analysis and visualization of medical images. It is utilized by radiologists and other imaging specialists to enhance diagnostic accuracy.
FDA Clearance Information
Pathway
510K
Number
K201444 ↗
Decision Date
August 13, 2020
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 August 13, 2020. 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 assist clinicians in the visualization and analysis of medical images. It integrates various imaging modalities to provide comprehensive diagnostic insights. The software offers tools for semi-automatic and automatic volumetric analysis, enhancing the precision of image interpretation.
Clinical Applications
This device is commonly used in radiology departments for the segmentation and analysis of complex anatomical structures, such as pulmonary nodules. It supports clinicians in oncology, pulmonology, and other specialties that require detailed imaging analysis. The software is particularly useful in hospitals and imaging centers where high-resolution image processing is critical for patient care.
Indications for Use
The syngo via rt image suite is indicated for use in the analysis of medical images, particularly for conditions requiring detailed volumetric analysis, such as pulmonary nodules. It aids in the accurate assessment of anatomical structures in patients undergoing imaging studies.
Practical Considerations
The software is compatible with various imaging modalities and integrates seamlessly into existing radiology workflows. Clinicians should be familiar with its semi-automatic and automatic contouring tools to maximize its utility. Regular updates and training may be required to keep up with software advancements.
Related Literature
The linked study examined the precision of different volumetric tools for segmenting pulmonary nodules using a chest phantom model. It compared manual, semi-automatic, and automatic methods, including a deep-learning algorithm. The study found variations in precision across methods, highlighting the potential of automated tools. However, the study's limitations include its use of a phantom model rather than real patient data.
Frequently Asked Questions
What is syngo via rt image suite used for?
It is used for the analysis and visualization of medical images, particularly in the segmentation of anatomical structures like pulmonary nodules.
What specialties typically use this device?
Radiology, oncology, and pulmonology specialists commonly use this device for detailed image analysis.
What are the FDA-cleared indications?
The device is indicated for the analysis of medical images, particularly for conditions requiring detailed volumetric analysis such as pulmonary nodules.
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.