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510(k) Data Aggregation

    K Number
    K231047
    Device Name
    UniSyn Molecular Imaging (6-3-1)
    Manufacturer
    Convergent Imaging Solutions
    Date Cleared
    2023-09-01

    (142 days)

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

    Convergent Imaging Solutions

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure involving radioactive materials. UniSyn should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
    Device Description
    UniSyn Molecular Imaging (MI) is a Software as a Medical Device (SaMD) that supports the visualization, manipulation and analysis of medical image data acquired or used in radiology and nuclear medicine centers. UniSyn Ml is only intended to be used by qualified radiology and nuclear medicine professionals. Univer-interface components: a patient study browser and the UniSyn MI viewer. The software is available in both thick and can be integrated to launch from PACS software. Using UniSyn MI users can coregister anatomical and visualize them in fused and/or standalone display, e.g. single or multi-modal combinations of PET, SPECT, CT, and MR images. Users can also visualize and process planar nuclear medicine (NM) images acquired as single of multi-frame images. The layout of the UniSyn MI viewer is highly customisable, a typical layout for a PET/CT study would include of the PET and CT series in multiplanar reformatted (MPR) views as well as a 3D maximum-intensity (MIP) projection rendering of the PET series. UniSyn MI provides tools to zoom, pan, stack, and window-level the displayed series. Our triangulation tool can be used to localize a single anatomical point of interest among all MPR and MP views of the rest (RO) tools are available to delineate 2D and 3D regions and then compute image statistics within those regions, e.g. ROI area/volumes, minimum, mean and standard deviation of image pixel values. Various image segmentation tools are included with UniSyn MI to facilitate ROI delineation based on image pixel data. UniSyn MI includes a tool for absorbed dose estimation associated with internally deposited with diagnostic and therapeutic medical procedures. Absorbed dose estimates are based on single- or multi-time point activity measurements of molecular images and absorbed dose coefficients (S-Values) that are based on computational human models. Once a user has completed their review or analysis of a given study, UniSyn MI provides tools to generate reports and export exemplary image data to share with referring physicians to substantiate their findings.
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    K Number
    K081987
    Device Name
    UNISYN IMAGE FUSION, VERSION 1.0
    Manufacturer
    CONVERGENT IMAGING SOLUTIONS
    Date Cleared
    2008-09-26

    (74 days)

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

    CONVERGENT IMAGING SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT and MR scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
    Device Description
    UniSyn is a software only package designed for use on Intel Pentium and higher compatible computers running Microsoft Windows XP and later operating systems. It loads and writes images using a proprietary format. UniSyn provides the following features: - manual registration of images, where users can use user interface widgets to align the images in three dimensions; - automated registration of images from hybrid PET-CT and SPECT-CT scanners, which provide the registration parameters in their image headers; - multi-planar reformat (MPR) and image triangulation using cursors: linked transverse, sagittal and coronal views. When the user moves a cursor on one view, the corresponding orthogonal planes of the image are computed and displayed on the other. - image fusion with variable opacity - Maximum Intensity Projection (MIP) - 3D Render - Surface Render - 2D regions of interest and 2D statistics such as area - 3D volumes of interest and 3D statistics such as volume, average Standard Uptake Value (SUV) and maximum SUV - user configurable layouts: type of image (ie which modality and what type of display: one of MIP, MPR/), size, color map, position - can be preconfigured; - triangulation from MIP image: if the user clicks on the MIP image when it is in the coronal view, the MPR/fusion displays will update their position to that point - color maps individually assigned for fusion and non-fusion views - screen capture to clipboard and to disk
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