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510(k) Data Aggregation

    K Number
    K181460
    Device Name
    OnePacs System
    Manufacturer
    Date Cleared
    2018-10-11

    (129 days)

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

    OnePacs, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
    Device Description
    The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. The OnePacs system is a software only product and does not include any hardware accessories or peripheral devices. It is designed to work on generic PC hardware that meets minimum system requirements. The OnePacs System is comprised of following main interrelated software elements/ components: - OnePacs Cloud (OPS) - OnePacs Workstation (OPW) - OnePacs Workstation for macOS (OPX) - OnePacs Webviewer (OPWEBV) - OnePacs Study Retriever (OPSR) - OnePacs Gateway (OPG)
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