syngo Application Software
Siemens Medical Solutions, USA, Inc.The syngo Application Software by Siemens is a versatile medical imaging software that allows clinicians to view, manipulate, and process medical images in real time. It supports diagnostic image review and various interventional procedures by providing image-guided navigation, fusion of ultrasound with fluoroscopy, and 3D visualization to improve anatomical orientation and procedural accuracy. This software helps clinicians streamline complex procedures and enhances treatment planning and control.
Intended Use
Medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data, used for diagnostic image viewing, post-processing, and interventional procedures.
Technology
Software platform with common architecture supporting diagnostic review, post-processing, image fusion, and navigation; includes new syngo TrueFusion feature that fuses ultrasound with fluoroscopy images using machine learning for probe detection and automated co-registration; can be deployed on standalone hardware or integrated with Siemens angiography and fluoroscopy systems.
Performance
Non-clinical performance testing including software verification and validation was conducted; statistical validation of syngo TrueFusion on 28 phantom test data sets showed mean deviations within clinically acceptable limits (under 3mm); software found safe and effective compared to predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/10/2017
3 months - 2
FDA Approval
6/9/2017
Other devices from Siemens Medical Solutions, USA, Inc.
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