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510(k) Data Aggregation

    K Number
    K042692
    Device Name
    CLARITY FUSION
    Date Cleared
    2004-10-07

    (7 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHARED P.E.T. IMAGING, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To detect or image the distribution of radionuclides in the body or organ, using the following techniques: - Multiplanar Reconstruction (MPR) - Maximum/Minimum Intensity Projection (MIP) . - . Image Contrast Manipulation - Image Zoom Manipulation . - Automatic registration with Mutual Information Technique .
    Device Description
    Clarity Fusion is an option within the Clarity PET system so the end-user may differentiate between the two different applications within the same software program. This viewing of fused images is the ability to see the same datasets, as if they were being viewed independently, overlapped with each others. These fused images will allow a physician to look at two different datasets from different modalities. This is common medical practice that has now been computerized.
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    K Number
    K032866
    Device Name
    CLARITY PET
    Date Cleared
    2003-12-12

    (88 days)

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

    SHARED P.E.T. IMAGING, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To detect or image the distribution of radionuclides in the body or organ, using the following techniques: - Multiplanar Reconstruction (MPR) . - Maximum/Minimum Intensity Projection (MIP) . - Image Contrast Manipulation . - Image Zoom Manipulation . - Automatic registration with Mutual Information Technique .
    Device Description
    Clarity PET is PET intage review software. Clarity PET offers a comprehensive software solution for medical imaging tasks and applications. Clarity PET is a medical diagnostic workstation designed for display, review, 3D MPR, communication and archiving of medical images
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