Spectral CT Verida Family

The Spectral CT Verida Family is a computed tomography x-ray system that produces cross-sectional body images by reconstructing x-ray transmission data from different angles and planes. It acquires dual-energy spectra to analyze material composition and provides both conventional and spectral images for diagnostic imaging in radiology, interventional radiology, cardiology, oncology, and lung cancer screening in patients of all ages.

The device uses identical fundamental design and core components (gantry, detector, tube) as the predicate Spectral CT 7500 RT. New/modified features include: Spectral Precise Image (SPI) AI-based denoising, improved reconstruction speed (120 vs 40 images/sec), Noah RT-2 couch with motorized sub-pallet, Bayonet Head Holder for extended scan range, updated CPU/storage components, and software version 5.4. The dual-layer detector and spectral imaging capability remain unchanged from the predicate.

IEC 60601-1:2005 A1:2012 A2:2020 (general safety), IEC 60601-1-2:2014 A1:2020 (EMC), IEC 60601-2-44:2009 A1:2012 A2:2016 (CT equipment safety), IEC 62304:2006 + A1:2015 (software lifecycle), ISO 14971:2019 (risk management), ISO 10993-1:2018 (biocompatibility), and FDA guidance on software, cybersecurity, and clinical performance studies.

The proposed device is substantially equivalent to the Spectral CT 7500 RT (K240844) because it retains identical fundamental scientific technology, core hardware architecture, and spectral imaging principles. Design changes (SPI algorithm, couch upgrade, performance improvements) do not alter the basic image-formation process or introduce new clinical decision-making. Comprehensive verification, validation, clinical testing, and risk analysis confirm SPI meets or exceeds predicate performance with no new safety or effectiveness concerns.