Syngo Dynamics (Version VA40F)
Siemens Medical Solutions USA, Inc.Syngo Dynamics (Version VA40F) is a software medical device from Siemens designed to assist healthcare professionals in reviewing and analyzing medical images for disease detection and patient management. It supports multiple imaging modalities including ultrasound, x-ray angiography, CT, MR, nuclear medicine, and others, with applications primarily focused on cardiology, vascular, and fetal imaging. The software offers advanced image processing tools and semi-automated measurement capabilities such as left ventricular ejection fraction estimation, helping clinicians interpret complex imaging data efficiently within healthcare networks.
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, supporting clinicians in interpretation and analysis for disease detection, diagnosis, and patient management within the healthcare institution’s network.
Technology
Syngo Dynamics is a software-only medical image management and processing system based on client-server architecture. It supports multiple deployment models including standalone, EHR integrated, and Multi-Modality Cardiovascular (MMCV) deployment. It supports input from multiple imaging modalities and offers post-processing features such as image viewing, manipulation, and semi-automated quantitative analysis (e.g., left ventricular ejection fraction with AI/ML algorithms). Communication uses TCP/IP, DICOM, HL7, and HTTP protocols. The system also supports various image compression methods and provides multi-device access strategies including desktop, remote, web, and mobile devices.
Performance
Performance testing includes non-clinical validation and verification demonstrating that the device meets specified acceptance criteria. AI/ML-enabled semi-automated left ventricular ejection fraction (Auto EF) was validated on 150 cases across three US sites representing diverse patient populations and imaging manufacturers. The results showed strong correlation with ground truth established by expert sonographers using manual conventional methods (Pearson correlation r=0.827). Risk management and cybersecurity measures were implemented to ensure device safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/11/2022
3 months - 2
FDA Approval
11/14/2022
Other devices from Siemens Medical Solutions USA, Inc.
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