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

The NAEOTOM Alpha class CT scanner systems (including NAEOTOM Alpha, NAEOTOM Alpha.Pro, and NAEOTOM Alpha.Prime models) are whole-body X-ray computed tomography systems that generate cross-sectional images for diagnosis, treatment planning, radiation therapy, and interventional procedures. The devices use photon-counting detector technology and are available in dual-source and single-source configurations. They can be used for low-dose lung cancer screening in high-risk populations as defined by professional medical societies.

The subject devices feature the same fundamental hardware (QuantaMax detectors, VECTRON tubes, identical gantry specifications, patient tables) as the predicate K243523. Software has been updated from syngo CT VB20 to syngo CT VB20 (update) with three new features: HD FoV 5.0 (extended field-of-view reconstruction algorithm), ZeeFree RT (respiratory motion artifact reduction), and myExam Contrast (contrast parameter exchange). All prior software and hardware features from the predicate are retained unchanged; no features have been removed.

Recognized consensus standards include IEC 61223-3-5 (CT acceptance testing), IEC 60601-2-44 (CT equipment safety), IEC 62304 (software lifecycle), ISO 14971 (risk management), IEC 62366-1 (usability engineering), and NEMA XR 25-2019 (CT dose check). Testing also followed DICOM (PS 3.1-3.20), IEC 60601-1-3 (radiation protection), and IEC 60825-1 (laser safety).

The device is substantially equivalent because it uses identical hardware and control mechanisms as the predicate, retains all predicate software functionality without removal of any features, and the three new software modifications (HD FoV 5.0, ZeeFree RT, myExam Contrast) do not raise new safety or effectiveness questions. Bench testing with phantoms and retrospective blinded clinician evaluation demonstrate the new algorithms perform as safely and effectively as existing methods; verification and validation testing confirmed all software specifications met acceptance criteria with no relevant new artifacts or errors introduced.