Aquilion ONE (TSX-308A/3) V1.5

The Aquilion ONE (TSX-308A/3) V1.5 is a multi-slice helical CT scanner that acquires and displays cross-sectional images of the whole body, including the head, with the ability to image whole organs in a single rotation. The device includes advanced software features: FIRST (iterative reconstruction to reduce dose), AiCE (noise reduction using deep learning), spectral imaging (dual-energy CT via rapid kV switching), PIQE (deep learning reconstruction for spatial resolution), and CLEAR Motion (motion artifact reduction for lung imaging).

Compared to the predicate V1.4, the V1.5 adds CLEAR Motion (motion artifact reduction) and expands PIQE scan regions from cardiac/abdomen/pelvis to include lung. It adds CARDIAC option to the Spectral Imaging System (previously cleared separately under K213504). New features Connect Assistance and Area Finder are also included. The 3D Landmark Scan now uses only 120kV (predicate used 120/135kV).

Device conforms to IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC81001-5-1, IEC62366-1, NEMA XR-25, XR-26, and XR-29. Performance standards per 21 CFR §1010 and §1020 for radiation safety. Quality system per 21 CFR §820 and ISO 13485.

The V1.5 performs the same intended function as the predicate V1.4—whole-body CT imaging with advanced reconstruction—using the same fundamental system architecture (TSX-308A/3 gantry and technology). New features (CLEAR Motion, expanded PIQE lung capability, CARDIAC spectral imaging option) are either minor enhancements to existing cleared features or variants of features already cleared under previous submissions (K213504). Bench testing and clinical image review confirmed diagnostic quality equivalent to or better than the predicate device.