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    K Number
    K251401
    Device Name
    PennPET Explorer Positron Emission Tomograph
    Manufacturer
    Trustees Of The University Of Pennsylvania
    Date Cleared
    2025-11-25

    (203 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K172406,K081135,K123599
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PennPET Explorer PET system is a diagnostic imaging device that, together with the co-located IQon CT scanner, combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The IQon CT system images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET system images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. Together, these systems are used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology.

    The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. The CT scanner can also be operated as fully functional, independent diagnostic tool, including for use in radiation therapy planning.

    Device Description

    The PennPET Explorer is based on the PET technology of its predicate device, the Philips Vereos PET/CT scanner, but follows the model of its reference device, the previous Philips Gemini TF PET/CT by having co-located—yet separated—PET and CT scanners served by a common patient table. The PennPET Explorer uses a newly designed 142 cm axial field-of-view (AFOV) PET gantry and is intended to be used with a co-located Philips IQon multi-energy CT and patient table.

    The PennPET Explorer PET gantry is a modular system comprising six PET detector rings stacked axially, yielding a 142 cm axial FOV. This allows imaging of the human head, torso, and upper legs in a single frame without moving the patient. The entire imaging chain of components from the detectors to the data acquisition computers is supplied by Philips and consists of components that are used in the Vereos PET scanner. The mechanical structure and data processing software have been modified and developed to handle the additional data from all six PET rings simultaneously.

    Each of the six detector rings is substantially equivalent to a Philips Vereos PET scanner.

    AI/ML Overview

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