Siemens Medical Solutions USA, Inc. · Class II · Cleared Jul 3, 2025
| K-number | K250822 |
| Device name | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product code | JAK |
| Device class | Class II |
| Decision date | Jul 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1750 |
The SOMATOM go. Platform and SOMATOM Pro.Pulse are computed tomography (CT) X-ray systems that generate cross-sectional images of patients for diagnosis, treatment planning, and therapeutic interventions. The submission covers a new software version (syngo CT VB20) that enables enhanced functionality while maintaining the same fundamental imaging principles and indications for use as the predicate devices.
The subject devices retain identical hardware specifications (detector technology, X-ray tube, gantry bore, generator power) compared to predicates but introduce software modifications including CARE Moodlight enablement, new Eco Power Mode, HD FoV 5.0 reconstruction algorithm, ZeeFree RT stack artifact reduction, Oncology Exchange integration, DirectSetup Notes, and myAblation Guide interface. All previously cleared features remain unmodified and no features have been removed.
IEC 61223-3-5 (CT acceptance testing), IEC 60601-2-44 (CT equipment safety), IEC 60601-1-3 (radiation protection), IEC 62366-1 (usability engineering), IEC 62304 (software lifecycle), and NEMA XR 25-2019 (CT dose check). Bench testing included phantom studies for image quality, algorithm validation, and retrospective blinded rater studies by board-approved radiologists and physicists.
The subject devices are substantially equivalent because they use identical hardware, materials, energy sources, and control mechanisms as the predicates while reusing all unmodified cleared software features from VB10. The new software modifications provide enhanced functionality without changing the fundamental CT imaging technology or introducing new safety concerns. Comprehensive verification, validation, and phantom testing demonstrated the new features perform comparably or better than predicates without introducing relevant errors, artifacts, or hazards. The indications for use, intended patient population, and clinical application remain unchanged.
View the full FDA submission: accessdata.fda.gov