Siemens Medical Solutions USA, Inc. · Class II · Cleared Apr 29, 2026
| K-number | K254184 |
| Device name | syngo Application Software |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product code | QIH |
| Device class | Class II |
| Decision date | Apr 29, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
The syngo Application Software is medical diagnostic software for real-time viewing, image manipulation, 3D visualization, communication, and storage of medical images and data. It is used for diagnostic image viewing and postprocessing during interventional procedures, and can be deployed on standalone workstations, Siemens X-ray systems, or angiography systems to support image-guided surgical, interventional cardiology, oncology, radiology, and neuroradiology procedures.
The subject device (VE51A) contains updated and new software features compared to the predicate (VE40C), including: updated myScrew Path Assist, updated syngo Embolization Guidance user interface, updated syngo TrueFusion with enhanced security, new CleanEdge postprocessing option, new syngo DynaCT Bone Removal with AI-based segmentation, new syngo DynaCT MORE for motion compensation, updated Contour Enhanced Overlay, and updated QuantWeb with ARTIS Touch UI compatibility. The fundamental technology and intended use remain the same.
ISO 14971 (risk management), ISO 15223-1 (device labeling symbols), ISO 20417 (manufacturer-supplied information), IEC 82304-1 (health software safety), IEC 62304 (software lifecycle), IEC 62366-1 (usability engineering), IEC 80001-1 (IT network risk management), IEC 81001-5-1 (health software security), DICOM PS 3.1–3.20, ANSI UL 2900-1 and 2900-2-1 (cybersecurity), AAMI TIR57 and SW96 (medical device security), and AAMI TIR45 (AGILE development guidance).
The subject device is substantially equivalent to the predicate because it maintains the same intended use, general indications for use, and classification regulation (21 CFR 892.2050). All software modifications are optional enhancements that do not alter the fundamental scientific technology. Verification and validation testing, including quantitative segmentation accuracy metrics (Dice coefficient ~0.95, IoU ~0.90 for bone removal; 100% acceptance rates for clinical validation), and human factors analysis demonstrate the device is safe and effective for its intended users and applications.
View the full FDA submission: accessdata.fda.gov