Spectral CT

The Spectral CT system is a computed tomography X-ray system that produces cross-sectional images of the body by computer reconstruction of X-ray transmission data. It acquires dual-energy spectral data (higher and lower energy X-ray spectra) to analyze material composition and generate images at selected energies, providing information about chemical composition, attenuation, material density, and effective atomic number. It is indicated for head, whole body, cardiac, and vascular CT applications in patients of all ages, including low-dose lung cancer screening, diagnostic radiology, interventional radiology, cardiology, and radiation therapy planning.

The proposed device shares identical fundamental design and technology with the primary predicate (K203020) including: 128 slices of 0.625mm, continuous rotation gantry, 800mm bore, identical spatial resolution (16 lp/cm high mode), dual-layer scintillator detectors, and identical generator/tube specifications (120kW, 80-140 kV). New features include: Extended Field of View (EFOV) up to 800mm for non-gated helical scans (identical to secondary predicate K240844) and Pulmonary Gating 4DCT for radiation therapy planning (also from K240844). All other specifications including scan modes, couch parameters, and reconstruction methods remain identical.

IEC 60601-1:2005 A1:2012 A2:2020 (general safety), IEC 60601-1-2:2014 A1:2020 (EMC), IEC 60601-1-3:2008 A2:2021 (radiation protection), IEC 60601-1-6:2010 (usability), IEC 60601-2-28:2017 (X-ray tube assemblies), IEC 60601-2-44:2009 A1:2012 A2:2016 (CT equipment), IEC 62304:2006 (software lifecycle), ISO 14971:2019 (risk management), and ISO 10993-1:2018 (biocompatibility). Design verification and validation testing demonstrated compliance with system requirements specifications.

The proposed device is substantially equivalent because it shares identical fundamental scientific technology and design with the primary predicate K203020 across all core specifications (detector type, gantry design, image matrix, spatial resolution, noise performance). The two new features—Extended Field of View and Pulmonary Gating 4DCT—are directly borrowed from the already-cleared secondary predicate K240844 and raise no new safety or effectiveness concerns. Non-clinical testing including phantom-based image quality assessment and clinical image evaluation confirmed performance is equivalent to predicates. The minor design differences do not alter the intended use, principles of operation, or safety profile.