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510(k) Data Aggregation

    K Number
    K210450
    Device Name
    BBX-PET Scanner
    Manufacturer
    Prescient Imaging, LLC
    Date Cleared
    2021-03-17

    (29 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Prescient Imaging, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BBX™-PET scanner is intended to obtain positron emission tomography (PET) images of parts of the human body that fit in the patient aperture (e.g., head) to detect abnormal pattern of radioactivity after injection of a positron emitting radiopharmaceutical. This information can assist in research, diagnosis, therapeutic outcome assessment.
    Device Description
    The BBX-PET Scanner is a Positron Emission Tomography (PET) system to image the distribution of injected positron emitting radiopharmaceuticals into live humans or animals. The BBX-PET Scanner produces images that represent the internal distribution of radioactivity in the head. The BBX-PET Scanner is comprised of two parts; the Gantry containing detectors and electronics, and the Universal Console that contains the computer workstation. These two parts are connected to each other using optical fiber and an USB cable. The detector assembly is composed of scintillation crystal Lutetium Fin-Silicate (LFS) and light detector photomultiplier. These detectors are arranged on the surface of a cylindrical shell with the diameter of 29 cm in the Gantry. Various electronic circuits are used to process and digitize the signals of these detectors and process the data and store in the computer of the Universal Console for image reconstructions and display.
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