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510(k) Data Aggregation

    K Number
    K090178
    Device Name
    ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8
    Manufacturer
    NEUSOFT POSITRON MEDICAL SYSTEMS CO., LTD
    Date Cleared
    2009-04-24

    (88 days)

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

    NEUSOFT POSITRON MEDICAL SYSTEMS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PET scanner is intended to be used for whole body, multi-slice, Positron Emission Tomography diagnostic imaging.
    Device Description
    The Positron Emission Tomography (PET) scanners from Neusoft Positron Medical Systems Corporation image the distribution of positron-emitting radionuclides in the human body. These software-controlled medical devices use positron emitting radioactive isotopes to create cross-sectional tomographic images that show function or metabolism, rather than anatomy, as in conventional scanning techniques. The PET scanner's software generates quantitative images through Attenuation Correction, which corrects for loss of information due to absorption and scatter by overlying soft tissue, and through theoretical, measured, or hybrid (segmented attenuation correction) Image Reconstruction, which generates transaxial images from acquired data using a filtered back projection or iterative reconstruction process. The PET scanner consists of Detector System, Gantry, Front-end Electronics, Patient Table, Transmission Source, Operator's Control Workstation, Image Processing Workstation and optional Remote Display Workstation.
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