SCENARIA View Phase 5.0

The SCENARIA View Phase 5.0 is a 128-slice multi-detector CT imaging system that acquires axial volumes of the whole body including the head in axial, helical, or dynamic modes. It supports post-processing with multi-planar reconstruction and volume rendering, and includes a Low Dose CT Lung Cancer Screening option. The system is intended for general populations and can be used for interventional needle guidance.

The subject device shares the same gantry, detector, X-ray tube, and X-ray generator design as the predicate SCENARIA View 4.2. Key differences include: patient table maximum load capacity increased from 250 kg to 300 kg; addition of AutoPose (AI-based automatic scan range setting), RemoteRecon (external PC-based reconstruction parameter setting), and Body Still Shot (motion artifact reduction for chest); and expansion of AutoPositioning from 2 supported body parts (Head, Chest) to 14 body parts.

ANSI AAMI ES60601-1:2005 with amendments; IEC 60601-1-2 Edition 4.1 (EMC); IEC 60601-1-3 Edition 2.2 (radiation protection); IEC 60601-2-44 Edition 3.2 (CT equipment); IEC 62304 Edition 1.1 (software lifecycle); NEMA XR 25 (CT dose check); and IEC61223-3-5 (bench testing basis). Testing confirmed spatial resolution, noise, CT number uniformity, and tomographic section thickness met 21 CFR 1020.33(c) and (g).

The device is substantially equivalent because the fundamental hardware architecture, scanning principles, reconstruction algorithms, and image quality characteristics remain identical to the predicate device. All new software features (AutoPose, RemoteRecon) and modified features (increased table load, expanded body part support, Body Still Shot) operate within the same technological framework without changing the underlying CT imaging process or introducing new intended uses. Non-clinical bench testing confirmed equivalent basic performance metrics, and clinical testing of AutoPose and Body Still Shot demonstrated safe and effective operation across multiple anatomical regions without necessitating different regulatory controls than the predicate.