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510(k) Data Aggregation

    K Number
    K180549
    Device Name
    ZED Link
    Manufacturer
    Date Cleared
    2018-04-12

    (42 days)

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

    Zed Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ZED LINK™, is an image management system whose intended use is to provide scalable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, retrieve and display images and data from all image 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. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. ZED LINK™, is not intended for diagnostic image review on mobile devices. Typical users of this system are doctors and health care professionals.
    Device Description
    ZED LINK™ has four main uses: - Hard copy replacement: Replaces hard-copy media for managing medical images, such as film archives. - Remote access: Expands the possibilities of conventional systems by providing capabilities of off-site viewing and reporting (distance education, tele review). It enables practitioners in different physical locations to access the same information simultaneously for teleradiology. - Electronic image integration platform: Provides the electronic platform for radiology images interfacing with other medical automation systems such as Hospital Information System (HIS), Electronic Medical Record (EMR), Practice Management Software, and Radiology Information System (RIS). - Radiology Workflow Management: Used by radiology personnel to manage the workflow of patient exams.
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