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510(k) Data Aggregation

    K Number
    K973396
    Device Name
    QUEST PET IMAGING SYSTEM
    Date Cleared
    1998-01-21

    (149 days)

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

    UGM MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Quest Positron Emission Tomography (PET) system is a whole body scanner designed to provide true volumetric imaging. Quest is intended for use as a diagnostic imaging device. When used with appropriate radiopharmaceuticals, it produces images representative of the internal distribution of radioactivity in the head or the body.
    Device Description
    The Quest Positron Emission Tomography (PET) system is a whole body scanner designed to provide true volumetric imaging. Quest is intended for use as a diagnostic imaging device. When used with appropriate radiopharmaceuticals, it produces images representative of the internal distribution of radioactivity in the head or the body. The system allows you to reconstruct high-resolution three-dimensional, static, gated or dynamic images of biochemical and metabolic processes and then enables you to display, process and analyze these images according to your specific needs. PET is based on the fact that certain radionuclides decay by positron emission. The positron annihilation results in the emission of two 511 keV gamma-rays which are emitted in opposite directions. Coincidence detection of both gamma rays localizes the decay along a line. By using 6 large position-sensitive detectors around the patient, counts along many parallel lines and at many angles are acquired simultaneously. By using reconstruction algorithms, the internal distribution of radioactivity can be determined. The scanner provides a 25 cm axial field of view for whole-organ coverage, as well as a 50 cm transverse scan field of view for body studies. The Ouest uses 6 rectangular NaI(Tl) scintillation crystals, each of which is coupled to 48 photomultipliers (PMTs). 42 of the (PMTs) are 2.5 inch diameter round arranged in a close packed hexagonal pattern, and the remaining six are half-hex (PMTs) positioned at the edges to fill out the rectangular crystal area. The detector separation is 85 cm.
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