Siemens Healthcare GmbH · Class II · Cleared Apr 3, 2025
| K-number | K242551 |
| Device name | syngo Dynamics (Version VA41D) |
| Applicant | Siemens Healthcare GmbH |
| Product code | QIH |
| Device class | Class II |
| Decision date | Apr 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
syngo Dynamics (Version VA41D) is a software-only medical image management and processing system designed for cardiology and multimodal medical imaging. It allows trained healthcare professionals to review, manipulate, and analyze medical images from ultrasound, X-ray angiography, CT, MR, and nuclear medicine studies, generating quantitative data and diagnostic reports within a healthcare institution's network.
The subject device maintains identical architecture (client-server), supported modalities (US, XA, DX, CT, MR, SC, NM, PT, ECG), deployment options (standalone with DICOM server, EHR-integrated, multimodality cardiovascular), communication protocols (TCP/IP, DICOM, HL7, HTTP), and compression methods (lossless 2-3x and lossy JPEG/MP4) as the predicate. The primary difference is an enhanced Auto EF algorithm that was re-trained with additional annotated data to improve left ventricular ejection fraction calculation performance from ultrasound images.
Conformance to NEMA PS 3.1-3.20 (2023e), ISO IEC 10918-1, IEC 62366-1, ISO 14971 (risk analysis), IEEE Std 3333.2.1-2015, IEC 62304 (software lifecycle), IEC TR 80001-2-2 (network security), and IEC 82304-1 (health software). Software verification and validation conducted per FDA guidance on device software functions (Basic Documentation Level).
The indications for use are identical to the predicate device. All technological characteristics, deployment strategies, and core functionalities remain unchanged. The Auto EF algorithm enhancement was validated using the same test methodology, acceptance criteria (Pearson's r ≥0.800), and independent test dataset (n=150) as the predicate, demonstrating equivalent or superior performance (biplane EF correlation 0.822 vs. 0.826 for predicate). Risk analysis confirmed no new safety concerns, and users retain ability to review, edit, or reject algorithm-generated results. The device does not contact patients and is used only by trained professionals, with clinician review providing oversight for any malfunctions.
View the full FDA submission: accessdata.fda.gov