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

Ready to Sharpen Your Edge?

Subscribe to join 7,600+ peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.