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510(k) Data Aggregation

    K Number
    K172490
    Device Name
    eUnity
    Manufacturer
    Client Outlook Inc.
    Date Cleared
    2018-02-06

    (173 days)

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

    Client Outlook Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    eUnity is a software application that displays medical image data and associated clinical reports to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data. eUnity allows users to perform image manipulations, including window/level, rotation, measurement and markup. eUnity provides 2D display, Multi-Planar Reformating and 3D visualization of medical image data, and mobile access to images. eUnity displays both lossless and lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes. Display monitors or mobile devices used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. For mobile diagnostic usage when a full workstation is not available. Mobile usage for mammography is for reference and referral only.
    Device Description
    Client Outlook has developed eUnity to load, display and manipulate medical (DICOM) images within a web-browser without installing client software. eUnity is a server-based software solution that extends common web-browsers on the most popular operating systems into medical review stations; removing a technical barrier that had long been a key contributor to poor medical image access. eUnity is an enterprise medical image viewer that provides access to full quality images from anywhere using nothing more than a standard web browser. Combined with a calibrated monitor, it can be used to make diagnostic decisions. Secure, fast, immediate access to information means less time spent searching for specialized workstations and supports greater efficiency for care, greater collaboration, and faster turnaround times. This device is the successor to eUnity predicate (K161515) and adds the following functionality: MIP/MPR/3D and Mobile Diagnostic Use.
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    K Number
    K161515
    Device Name
    eUnity
    Manufacturer
    Client Outlook Inc.
    Date Cleared
    2016-11-15

    (166 days)

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

    Client Outlook Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    eUnity is a software application that displays medical image data and associated clinical reports. eUnity performs operations relating to the transfer, storage, display, and measurement of image data. eUnity allows users to perform image manipulations, including window/level, rotation, measurement and markup. eUnity displays both lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.
    Device Description
    eUnity is a software application that displays medical image data and associated clinical reports. eUnity performs operations relating to the transfer, storage, display, and measurement of image data. eUnity allows users to perform image manipulations, including window/level, rotation, measurement and markup. eUnity displays both lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes.
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