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510(k) Data Aggregation

    K Number
    K090553
    Device Name
    NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER
    Manufacturer
    Date Cleared
    2009-03-31

    (29 days)

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

    NAVISCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Naviscan PEMFlex Solo II High Resolution PET Scanner 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 Naviscan, Inc. (Naviscan) PEMFlex Solo II High Resolution PET Scanner (Solo II) is a high spatial resolution, small field-of-view PET imaging system specifically developed for close-range, spot, i.e. limited field, imaging. The Solo II is a partial-ring PET scanner, equipped with lutetium-containing gamma-ray detectors, which collects gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body. The Solo II is designed to collect gamma rays from a patient's body part with high efficiency. In order to achieve this high efficiency, the detectors should be positioned as close as possible to the body part under examination. Properly configured, the Solo II can display images obtained from other digital imaging modalities for correlative purposes.
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