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510(k) Data Aggregation

    K Number
    K122026
    Device Name
    PRISM ACQUIRE PRISM PROCESS PRISM VIEW
    Date Cleared
    2012-09-21

    (72 days)

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

    PRISM CLINICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prism Acquire® / Prism Process® software is 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. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets. Prism Acquire 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 Prism Process, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion. Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, 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 central nervous system pathology and the planning and monitoring of medical treatments.
    Device Description
    Prism Acquire provides a scripted approach to performing fMRI and other imaging studies. Prism Process performs post-processing and quality assurance of fMRI and other imaging data sets. The processed data is prepared for report generation utilizing the Prism View product, supporting the visualization and manipulation of clinical imagery of multiple kinds. It provides a flexible set of display, analysis, and export options for utilizing the imagery relationships. These applications may communicate in the healthcare IT environment via Prism Flow®, server-based software facilitating DICOM communications, authorization/authentication, audit logging, and other infrastructure functions.
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    K Number
    K082964
    Device Name
    PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)
    Date Cleared
    2009-03-09

    (157 days)

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

    PRISM CLINICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prism Acquire® / Prism Process® software is 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. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets. Prism Acquire 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 Prism Process, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion. Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, 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 central nervous system pathology and the planning and monitoring of medical treatments.
    Device Description
    Prism Acquire provides a scripted approach to performing fMRI and other imaging studies. Prism Process performs post-processing and quality assurance of fMRI and other imaging data sets. The processed data is prepared for report generation utilizing the Prism View product, supporting the visualization and manipulation of clinical imagery of multiple kinds. It provides a flexible set of display, analysis, and export options for utilizing the imagery relationships. These applications may communicate in the healthcare IT environment via Prism Flow®, server-based software facilitating DICOM communications, authorization/authentication, audit logging, and other infrastructure functions.
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    Ask a specific question about this device

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