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510(k) Data Aggregation

    K Number
    K121023
    Device Name
    SPECTRUM V.0
    Date Cleared
    2012-05-31

    (57 days)

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

    INTRINSIC MEDICAL IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IMI Spectrum V.0 is a medical diagnostic system that allows the processing, review, and analysis of multi-dimensional digital images acquired from CT imaging devices. The IMI Spectrum V.0 is not meant for primary image interpretation in mammography. The IMI Spectrum V.0 is intended to receive patient specific data sets of CT images and can be used for: - . 3D presentation of complex anatomical relationships and specified structures with the complete data set; - . System generation of a 3D model of the desired anatomical structure; - . Viewing of the volume rendered and Multiplanar Reconstruction (MPR) representations of the desired anatomical structure providing additional supplemental information to support interpretation and treatment planning; - Viewing the inner and outer surfaces of organs as well as within their wall providing . additional supplemental information to support interpretation and treatment planning; - Planning and following a navigation path through the desired anatomical structure; . - Programmed and interactive navigation and flythrough within the 3D volume including . specified organs and structures; - . Measurement of position and length of anatomical structures within the 3D volume; and - Common core technology with specialized interfaces for different anatomical structures.
    Device Description
    IMI Spectrum V.0 is a medical diagnostic device that allows the processing, review, and analysis of multi-dimensional digital images acquired from a variety of imaging devices. The IMI Spectrum V.0 contains all the required hardware and software to provide an interactive 3D and 2D views of diagnostic CT images. The views include both inner and outer surface 3D volume rendered images as well as orthogonal and multiplanar reformatted 2D images. This ability to view the dataset in different perspectives from which it was acquired is performed by first transferring DICOM images from the CT scanners to the IMI Spectrum V.O, semi-automatically identifying regions of interest and displaying these regions to the user in the above mentioned views. The user can navigate both freely within the dataset/region of interest, or follow automatically computed paths to move through or move around the outside of the structure. Measurements of the viewed anatomical structure can be made. The IMI Spectrum V.0 provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The IMI Spectrum V.0 user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including: - Select images for closer examination from a gallery of up to six 2D or 3D views . - Interactively manipulate an image in real-time to visualize anatomy and . pathology - Annotate, tag, measure, and record selected views .
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