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510(k) Data Aggregation

    K Number
    K120851
    Device Name
    COMMUNIFY PACS VIEWER
    Date Cleared
    2013-02-19

    (335 days)

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

    COMMUNIFY HEALTH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Communify PACS Viewer 1.5 is a Picture Archiving and Communications System (PACS) viewer designed to be used to view Digital Imaging and Communications in Media (DICOM), DICOM-RT and non-DICOM information and data. The Communify PACS Viewer 1.5 is a software application that runs on standard "off-the-shell" personal computers, business computers, and servers running standard operating systems. Communify PACS Viewer is an image and display software that accepts DICOM data from any OEM modality which supports DICOM standard imaging data; the system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulations, create graphical representations of anatomical areas, and perform quantitative measurements. Communify PACS Viewer 1.5 is designed to support the use and viewing of DICOM-RT (radiotherapy extensions), such as Structure Set, Contour, Dose, Dose Value Histogram and Plan information. In Communify PACS Viewer 1.5, mammographic images should only be viewed on mammography monitors that are cleared or approved by FDA. Users should not apply lossy compression to mammographic images and only DICOM "for presentation" mammography images may be displayed. Communify PACS Viewer 1.5 does not manipulate or edit any mammography image acquisition system manufacturer's proprietary image processing methods. Please note that Communify PACS Viewer 1.5 does not run on mobile smartphones and tablets.
    Device Description
    Communify PACS Viewer (version 1.5) is a Picture Archiving and Communications System (PACS) viewer application which allows users to view, manipulate, annocate, transmit to other facilities, print, and animate all manners of DICOM and DICOM-RT images and modalities include, but are not limited to, CR, CT, DX, MR, NM, PT, RF, US, and XA. Communify PACS Viewer 1.5 contains common image manipulation functions (such as zoom, pan, triangulation, and window/level) and common image labeling tools (including measurements tools, drawing tools, and annotation overlays). The annotation overlay displays all the important metadata (as configured by the user) for each displayed series study. Although annotation fields depend on the modality and the patient study, the Annotation Overlay Template Wizard provides a full list of annotation fields the user can assign into the image display. For RT studies, Communify PACS Viewer 1.5 allows the visualization of the RT Structure Set, Dose, Dose Value Histogram, and Plan data. There are shortcut keys, toolbars, and right-click menus for easy access to tools and features. The Hanging Protocol editor of the Communify PACS Viewer configures the presentation layout of images on the screen when a study is loaded. This allows commonly used display formats and presets to be saved and easily accessed to allow for faster case study reviews.
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