syngo Application Software
Siemens Medical Solutions USA, Inc.syngo Application Software by Siemens Medical Solutions USA, Inc. is a medical software platform that enables real-time viewing, manipulation, 3D visualization, and storage of medical images. It supports diagnostic workflows and interventional procedures by providing image-guided solutions in various clinical specialties such as surgery, cardiology, oncology, and neuroradiology. The software enhances image analysis and treatment planning, improving workflow and clinical decision-making for healthcare professionals.
Intended Use
The syngo Application Software is a medical software for real-time viewing, image manipulation, 3D visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and postprocessing and for viewing and postprocessing during interventional procedures.
Technology
This software operates on standalone diagnostic workstations or networked systems and can be integrated with Siemens Healthineers angiography, fluoroscopy, or radiographic systems. It includes updated modules such as myScrew Path Assist for spine surgery, syngo Embolization Guidance for vascular interventions, syngo TrueFusion for image fusion with ultrasound, and enhancements for bone removal and motion compensation in DynaCT datasets. It utilizes AI-driven segmentation and processing techniques to assist clinical workflows.
Performance
The device underwent extensive nonclinical verification, validation, and performance testing following applicable standards (ISO 14971, IEC 62304, IEC 62366-1, etc.). Specific new features were clinically and quantitatively tested, including AI-based bone removal with high segmentation accuracy and clinical validation, image quality and diagnostic utility evaluations of DynaCT MORE showing non-inferiority to conventional reconstructions, and usability testing confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
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