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510(k) Data Aggregation

    K Number
    K032063
    Device Name
    PEM 2400 PET SCANNER
    Manufacturer
    Date Cleared
    2003-08-18

    (46 days)

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

    PEM TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PEM 2400 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 PEM 2400 PET Scanner is a high spatial resolution small field-of-view PET imaging system specifically developed for close-range spot imaging. The PEM 2400 PET Scanner is a partial-ring PET scanner, equipped with lutetiumcontaining 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 PEM 2400 PET scanner 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. The PEM 2400 PET Scanner can display images obtained from a digital imaging modality for correlative purposes.
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    K Number
    K003775
    Device Name
    PORTABLE BREAST COMPRESSION DEVICE
    Manufacturer
    Date Cleared
    2001-01-12

    (37 days)

    Product Code
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    PEM TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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