NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime

The NAEOTOM CT scanner systems (Alpha.Peak/Alpha, Alpha.Pro, and Alpha.Prime) are computed tomography X-ray systems used to generate cross-sectional images of patients for diagnosis, treatment planning, radiation therapy planning, and diagnostic/therapeutic interventions. They can be used for low-dose lung cancer screening in high-risk populations.

The subject devices use QuantaMax photon-counting detectors with 0.2 mm slice width, VECTRON tubes, and support both single-source (Alpha.Prime) and dual-source (Alpha, Alpha.Pro) configurations. Key modifications include new software version SOMARIS/10 syngo CT VB20 with added features for radiation therapy planning, respiratory motion management interfaces (Anzai, Varian RGSC, Open Online Interface), FAST 4D, Direct i4D, DirectBreathhold, Recon&GO with RT planning support, Oncology Exchange, CARE Moodlight, Eco Power Mode, and Direct Laser Steering.

IEC 61223-3-5 (CT imaging performance), IEC 60601-2-44 (CT X-ray equipment safety), IEC 60601-1-3 (radiation protection), NEMA XR 25-2019 and XR 28-2018 (CT dose requirements), IEC 62304 (medical device software lifecycle), ISO 14971 (risk management), and IEC 62366-1 (usability engineering).

The subject devices reuse all unmodified software features from the cleared predicate NAEOTOM Alpha (syngo CT VB10) and share the same fundamental scanner principle, detector technology, X-ray tube, gantry specifications, and patient table compatibility. Modifications are either enabled features already cleared in other Siemens CT systems (SOMATOM X.ceed platform) or new software additions that enhance functionality without changing the core imaging mechanism. Non-clinical testing including phantom studies, system integration, image quality evaluation, and bench testing demonstrate that the subject devices perform comparably to predicate devices for all intended uses including low-dose lung cancer screening and radiation therapy planning.