OmniTom Elite with PCD

The OmniTom Elite with PCD is a computed tomography (CT) system designed for x-ray imaging of anatomy that fits within a 40 cm aperture, primarily the head and neck. It is intended for both pediatric and adult patients, offering multi-energy CT functionality with spectral imaging capability for material decomposition and virtual monoenergetic images.

The subject device has identical design, components, and detector coverage (16×0.707 mm standard, 26×0.424 mm high resolution, 80×0.141 mm ultra-high resolution) to the predicate device. The primary difference is software enhancement to expand intended use for pediatric scanning, with scan capabilities from 80–120 kV and currents of 5–40 mA.

Device conforms to FDA recognized consensus standards including AAMI/ANSI ES 60601-1 (2021), IEC 60601-1-2 (2020), IEC 60601-1-3 (2021), IEC 60601-2-44 (2016), IEC 62304 (2015), ISO 14971 (2019), and FDA performance standards 21 CFR §1020.30 and §1020.33 (2023). Additional standards include NEMA XR 25, 26, 28, 29 and DICOM PS 3.1–3.20.

The subject and predicate devices are both CT systems with identical overall design, basic functionality, and component specifications; the only technological difference is software enhancement for pediatric imaging protocols. Comprehensive testing demonstrated comparable image quality, identical detector specifications, equivalent multi-energy applications using the same calibration methods and energy binning, and conformance to all applicable standards, establishing that the new pediatric features do not introduce new safety or efficacy concerns.