📋 FDA Reference
Syngo via Rt Image Suite
Siemens Medical Solutions U
Summary: The syngo via rt image suite is a medical imaging software used for processing and analyzing radiological images, primarily in the context of dialysis-access devices. It is used by radiologists and clinicians to enhance diagnostic accuracy and treatment planning.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K151380 ↗
Decision Date ?
August 13, 2015
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, 2015. 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 an advanced imaging software platform designed to assist clinicians in the visualization and analysis of radiological images. It supports various imaging modalities and offers tools for image segmentation, volumetric analysis, and treatment planning. This software enhances the precision of diagnostic assessments and aids in the efficient management of patient data.
FDA-Cleared Indications
- For analysis and management of images related to dialysis-access devices.
- For assisting clinicians in evaluating dialysis vascular-access anatomy and planning related interventions.
Clinical Applications
- Reviewing radiological images of devices used for hemodialysis vascular access.
- Evaluating the position and appearance of dialysis-access devices on acquired medical images.
- Supporting assessment and treatment planning for patients with dialysis vascular access.
- Displaying and analyzing imaging data in radiology and interventional procedure workflows.
Practical Considerations
- This is software, not an implanted or disposable device; it does not have a physical diameter, length, or catheter size.
- Compatibility depends on the installed software version, imaging modalities, DICOM connectivity, workstation configuration, and hospital information systems.
- The software processes images obtained from compatible imaging equipment; image quality and the original acquisition protocol affect interpretation.
- It is not itself MRI-safe or MRI-unsafe in the way an implant is. MRI safety is determined by the scanner, accessories, and any patient devices being evaluated.
- Clinical decisions should be made by qualified clinicians and should not rely on software analysis alone.
Related Literature
The linked study examined the precision of various volumetry tools, including semi-automatic and automatic methods, for segmenting pulmonary nodules in a phantom chest model. The study found that different contouring approaches yielded varying results, with the deep-learning algorithm showing promise for automatic contouring. However, the study was limited by its use of a phantom model, which may not fully replicate clinical scenarios.
Frequently Asked Questions
What is syngo via rt image suite used for?
It is used for processing and analyzing radiological images, particularly in the context of dialysis-access devices.
What specialties typically use this device?
Radiologists and interventional nephrologists commonly use this device in settings focused on dialysis-access procedures.
What are the FDA-cleared indications?
The device is indicated for the analysis and management 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.