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510(k) Data Aggregation

    K Number
    K181318
    Device Name
    ONIS-PACS
    Date Cleared
    2018-08-13

    (87 days)

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

    DigitalCore Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ONIS-PACS is a software device intended to be used by healthcare personnel and intended for viewing, reviewing, performing measurements/quantifications and reporting of medical images and data acquired from DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy images and digitized film images must not be used for primary diagnosis or interpretation.
    Device Description
    ONIS-PACS is a Picture Archiving Communication System (PACS) fully compliant with the DICOM version 3.0 Standard. It is suitable for storing, distributing, retrieving, visualizing, manipulating, performing measurements/quantifications and reporting various DICOM objects. ONIS Viewer is a desktop application that makes it possible to visualize, manipulate and process medical images of many different modalities. Basic and advanced tools are provided for manipulating and processing images, including multi-planar reconstruction and 3D volume rendering. The software also includes a Local Server service running in the background that can send and receive DICOM images and can respond to DICOM queries. The ONIS Viewer and the Local Server applications must run on the same computer. ONIS Remote is a desktop application identical to the ONIS Viewer, except that it runs without the Local Server. It must connect to a Site Server to retrieve the studies to be retrieved and processed. WebONIS is an ActiveX component loaded into an HTML page that provides the same functionality as the ONIS Remote application. It can only be used with the Microsoft Internet Explorer browser. The browser must connect to a web server to load the ActiveX component, and the latter then connects directly to an ONIS Site Server or an ONIS Organization Server. ONIS Site Server is a server application that supports the storage and retrieval of a wide range of DICOM Storage objects. It also supports the storage and retrieval of graphical annotations and reports when connected to ONIS client applications (ONIS Viewer, ONIS Remote, and WebONIS). ONIS Organization Server is a server that provides a single access point to multiple Site Servers.
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