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510(k) Data Aggregation

    K Number
    K250928
    Date Cleared
    2025-09-08

    (164 days)

    Product Code
    Regulation Number
    892.1750
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OmniTom Elite with PCD computed tomography (CT) system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.

    The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast. The PCD CT system has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI).

    Device Description

    The subject OmniTom Elite with PCD Computed Tomography (CT) system provides the same functionality as the previous version of the device, OmniTom Elite (K233767). Both computed tomography systems are identical in terms of the high resolution, 16 row, 40 cm bore, and 30 cm field of view. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360-degree movement and electrical drive system so the system can be moved easily to different locations.

    OmniTom Elite system with photon counting detector (PCD) provides the ability to capture CT data in multiple energy bands that can provide information on material composition of different tissues and contrast media. The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images.

    AI/ML Overview

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