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510(k) Data Aggregation

    K Number
    K063031
    Device Name
    PRISM VIEW, MODEL
    Date Cleared
    2006-11-02

    (30 days)

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

    KYRON CLINICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prism View™ provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DTI). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.
    Device Description
    Prism View is an image processing software package for the visualization and manipulation of clinical imagery of multiple kinds. It brings sets of anatomical, physiologic and/or functional imagery into alignment and provides a variety of display and analysis options for utilizing the imagery relationships.
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    K Number
    K061255
    Device Name
    BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
    Date Cleared
    2006-06-13

    (40 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    KYRON CLINICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BrainAcquireRx™ / BrainProcessRx™ Data Suite is software used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. The BrainAcquireRx software application presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by the BrainProcessRx application, which performs post-processing for quality control and subsequent viewing of fMRI and other MRI data. These applications can also be used to assist in scripted data acquisition and post-processing of anatomical, functional, and physiologic MR imagery including magnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.
    Device Description
    The software provides support for functional MRI (fMRI) data acquisition and post-processing, as well as other anatomical, functional and physiologic MRI studies. BrainAcquireRx provides a scripted approach to performing fMRI and other functional, anatomical and physiologic MRI studies. BrainProcessRx performs post-processing of fMRI and other data sets. The processed data is ready for report generation utilizing the Kyron BrainViewRx™ Viewer.
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    K Number
    K052467
    Device Name
    BRAIN VIEWRX VIEWER, VERSION 1.0
    Date Cleared
    2005-12-20

    (103 days)

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

    KYRON CLINICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BrainViewRxTM provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DT). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.
    Device Description
    BrainViewRx is an image processing software package for the visualization and manipulation of clinical imagery of multiple kinds. It brings sets of anatomical, physiologic and/or functional imagery into alignment and provides a variety of display and analysis options for utilizing the imagery relationships.
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    Ask a specific question about this device

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