syngo Dynamics (VA41F)

syngo Dynamics (VA41F) is a software-only medical image management and processing system for cardiology. It enables clinicians to review, manipulate, and analyze medical images from multiple modalities (ultrasound, X-ray, CT, MR, nuclear medicine) and provides semi-automated measurement tools for disease detection, diagnosis, and patient management in healthcare facilities.

The subject device maintains identical architecture (client-server), supported modalities, image communication protocols (TCP/IP, DICOM, HL7, HTTP), and data compression methods as the predicate. Key differences include new AI/ML-enabled tools (Auto EF updated, Extended View Classification, Auto Measures) and removal of 2D/3D visualization functions (MPR, MIP/MinIP, VRT) and multi-modality cardiovascular configuration—changes that enhance existing functions without impacting current offerings.

Conformance claimed to NEMA PS 3.1–3.20 (2023e), ISO IEC 10918-1, IEC 62366-1, ISO 14971 Third Edition, IEEE Std 3333.2.1-2015, IEC 62304, IEC TR 80001-2-2, and IEC 82304-1. Verification and validation testing documented per FDA's June 2023 guidance on device software; risk analysis per ISO 14971.

Indications for use are identical to the predicate (syngo Dynamics VA41D, K242551). Technological characteristics are substantially similar across architecture, modalities, communication, and compression. Performance testing of three new AI/ML functions (Auto EF, Auto Measures, Extended View Classification) demonstrates equivalent or superior performance to ground truth using 150 test cases per function across three U.S. sites with diverse ultrasound manufacturers. The removal of visualization functions and deployment configurations does not impact clinical safety or effectiveness. Overall, the device is safe, effective, and performs as well as the predicate without introducing new safety risks.