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 for advanced visualization and analysis of radiological images, primarily in radiology and oncology. It is utilized by radiologists and oncologists to enhance diagnostic accuracy and treatment planning.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K211379 ↗
Decision Date ?
July 30, 2021
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 July 30, 2021, by Siemens Medical Solutions U. It is classified as a Class 2 device under the product code MUJ.
What It Is
The syngo via rt image suite is a sophisticated imaging software platform designed to assist clinicians in the visualization and analysis of complex radiological images. It integrates various imaging modalities and provides tools for 3D visualization, segmentation, and volumetric analysis. This software is particularly beneficial in oncology for assessing tumor size and response to treatment, as well as in radiology for detailed anatomical studies.
FDA-Cleared Indications
- Visualization and analysis of medical images to assist qualified health care professionals in diagnosis and treatment planning.
- Three-dimensional visualization, image segmentation, and volumetric analysis of radiological images.
- Use with compatible medical imaging data, including CT and MRI studies, according to the cleared software labeling.
Clinical Applications
- Review and analysis of CT and MRI images in radiology.
- Three-dimensional visualization of anatomy and disease findings.
- Segmentation and volumetric assessment of lesions or other structures when supported by the configured application.
- Image-based oncology assessment and treatment planning.
- Radiation therapy planning workflows when used with compatible systems and according to the software labeling.
Practical Considerations
- This is software rather than an implanted or disposable device; it has no patient-contacting size, diameter, or length.
- Compatibility depends on the installed version, supported imaging modalities, DICOM data, workstations, and connected clinical systems.
- MRI use refers to analysis of MRI images, not placement of the software or hardware in the MRI scanner room. MRI equipment and imaging protocols must follow their own safety requirements.
- Segmentation, measurements, and volumetric results are intended to assist clinicians and should be reviewed by qualified personnel rather than used as the sole basis for diagnosis or treatment.
- Installation, cybersecurity, software updates, user training, and integration with local radiology or oncology workflows require management by the health care facility and authorized service personnel.
Related Literature
The linked study examined the precision of different volumetry tools, including semi-automatic and automatic methods, for segmenting pulmonary nodules in a phantom chest model. The study found that automatic contouring using a deep-learning algorithm provided comparable results to manual and semi-automated methods. 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 advanced visualization and analysis of radiological images, aiding in diagnosis and treatment planning, particularly in oncology and radiology.
What specialties typically use this device?
Radiologists and oncologists commonly use this device in both hospital and outpatient settings.
What are the FDA-cleared indications?
The device is indicated for the visualization and analysis of medical images to assist in diagnosing and planning treatment for various conditions, especially in oncology and radiology.
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.