syngo Dynamics (Version VA41D)
Siemens Healthcare GmbHsyngo Dynamics (Version VA41D) is a vendor-neutral cardiology image and information system developed by Siemens Healthcare. It provides tools for medical image management, review, manipulation, and quantitative analysis, including AI-enhanced algorithms for cardiac ultrasound images to support clinicians in diagnosis and patient care. It integrates with hospital networks and supports multiple imaging modalities such as ultrasound, CT, and MRI, enhancing workflow and decision-making in cardiology.
Intended Use
syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images. It supports clinicians by providing image manipulation and quantification for use in interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within the healthcare institution’s network.
Technology
Software-only medical device operating on common IT hardware, supporting client-server architecture with multiple deployment options (standalone, integrated with EHR, multi-modality cardiovascular). Supports DICOM data communication and various image processing algorithms including semi-automated visualization and AI-enhanced Auto EF algorithm for left ventricular ejection fraction estimation from ultrasound images. The AI model is locked before integration and undergoes validation with extensive testing data.
Performance
Performance testing included non-clinical verification and validation, complying with recognized standards (e.g., IEC 62304, ISO 14971). The enhanced Auto EF algorithm was clinically validated using testing datasets from multiple US sites showing comparable or improved performance relative to predicate. No clinical studies were conducted; labeling and cybersecurity considerations are included. Future algorithm improvements are managed under a Predetermined Change Control Plan.
Predicate Devices
No predicate devices specified
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