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510(k) Data Aggregation

    K Number
    K200546
    Device Name
    ZeeroMED View
    Manufacturer
    O3 Enterprise SRL
    Date Cleared
    2020-05-05

    (63 days)

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

    O3 Enterprise SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZeeroMED View software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. ZeeroMED View displays and manages diagnostic quality DICOM images. ZeeroMED View is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only. ZeeroMED View is not intended for diagnostic use on mobile devices.
    Device Description
    The ZeeroMED View Software, or ZeeroMED View, is a Web-based DICOM medical image viewer that allows downloading, reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. ZeeroMED View is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. ZeeroMED View enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software.
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