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510(k) Data Aggregation

    K Number
    K214062
    Device Name
    Radialis PET Camera
    Manufacturer
    Date Cleared
    2022-02-04

    (39 days)

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

    Radialis Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Radialis PET Camera is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.
    Device Description
    The Radialis PET Camera is a high spatial resolution, small field-of-view PET imaging camera specifically developed for close-range, organ-targeted (i.e., limited field) imaging. The Radialis PET Camera is a partial-ring planar PET camera, equipped with lutetium-containing gamma-ray detectors, which collect gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to the relative concentrations of these radiopharmaceuticals in the body. The Radialis PET Camera is designed to collect gamma rays emitted by the injected radiopharmaceutical in a patient's body part with high efficiency.
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