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510(k) Data Aggregation

    K Number
    K202292
    Device Name
    UDE
    Date Cleared
    2020-10-05

    (54 days)

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

    EBM Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UDE software is intended to display images from CT, MR, CR, US, XA and SC for the trained physician 's diagnosis or referring purpose. UDE provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography diagnosis.
    Device Description
    UDE is a software device that can be installed on Apple iPad Pro. Through wireless network, user can login, query and display the images which are stored in heir existing UDE server. The device can be installed in iOS 9, 11, 12 and 13 version platform such as iPad /iPhone, but can't be installed in platforms other than iOS 9, 11, 12 and 13 version . The image display quality on iPad /iPhone will be almost the same as on iPad Pro when it is used for diagnosis purpose of CT, MR, US, XA and SC. However, if it is used for CR diagnosis purpose, we will strongly suggest that users should adopt iPad Pro. because the screen size of iPad Pro is larger than those of Apple® iPad/iPhone. Main features of UDE are listed below - Receive, Store, Retrieve, Display, and Process Digital Images(CT, MR, US, CR, Full- Field . Mammography, XA,SC etc.) - · The displayed CT, MR, CR,, US,XA and SC images can be diagnosed by the trained physicians. - . The displayed CT, MR, CR, Full- Field Mammography, US, XA and SC images can be referred by the trained physicians. Mammography images are not for diagnostic use - · Communication log file - · Auto delete old images (FIFO) - · Overlay labels - · User Authentication - Display of Clinical Patient Data . - Distance Calculation - · layout adjustment (1×1, 2×1, 1×2, 2×2) - · Pan - Zoom - Window Level - · Cine Loop - Mammography hanging protocol
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