SOMATOM X.cite; SOMATOM X.ceed

The SOMATOM X.cite and SOMATOM X.ceed are computed tomography (CT) X-ray systems that generate cross-sectional images of patients by computer reconstruction of X-ray transmission data. The images are used by trained clinical staff as an aid in diagnosis, treatment planning, radiation therapy planning, and diagnostic/therapeutic interventions, including low-dose lung cancer screening in high-risk populations.

The subject devices feature a continuously rotating tube-detector system operating on the fan-beam principle with a single X-ray source. Key hardware remains identical to the predicate (StellarInfinity detector, Vectron tube, 70–140 kV, tin filtration). The software version is upgraded from syngo CT VB10 to VB20, introducing 14 hardware and software modifications including CARE Moodlight, Open Online respiratory gating interface, Eco Power Mode, HD FoV 5.0, ZeeFree RT stack-artifact reduction, DirectDensity with stopping-power-ratio calculation, and several workflow enhancements (myExam Contrast, Oncology Exchange, FAST Planning extensions).

Recognized consensus standards include NEMA PS 3.1–3.20 (DICOM), IEC 61223-3-5 (CT acceptance testing), IEC 60601-2-44 (CT X-ray equipment), IEC 60601-1-3 (radiation protection), ISO 14971 (risk management), IEC 62304 (software lifecycle), and IEC 62366-1 (usability engineering). Non-clinical testing included system validation, integration, functional verification, image quality evaluation, and bench testing of FAST algorithms, HD FoV 5.0, Flex 4D Spiral, ZeeFree RT, and DirectDensity on phantoms.

The subject devices are substantially equivalent because they maintain identical hardware properties and fundamental CT scanner technology (scanner principle, acquisition system, detector, tube, generator, patient table) as the primary predicate (K233650). All modifications are either cleared features reused from other Siemens CT systems (secondary predicate K250822) or improvements to existing features (e.g., HD FoV 5.0 vs. 4.0, DirectDensity enhancements). Verification and validation testing demonstrates the devices perform comparably to predicates with no introduction of new safety concerns. The indications for use remain unchanged.