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510(k) Data Aggregation

    K Number
    K212984
    Device Name
    MiPACS HTML5 Web Viewer
    Date Cleared
    2021-11-12

    (56 days)

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

    LEAD Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MiPACS HTML5 Web Viewer, is a software device, that enables Users to view and manipulate medical images. Patient images/studies can be accessed by Users locally within the system or across a wide-area network at distributed locations. The MIPACS HTML5 Web Viewer requires no installation on the client's behalf and is compatible with any HTML5compliant web browser (e.g. Google Chrome. Microsoft Internet Explorer 10, Microsoft Edge, Mozilla Firefox, MacOS). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy, compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. MiPACS HTML5 Web Viewer, is not intended for diagnostic image review on mobile devices.
    Device Description
    MiPACS HTML5 is a medical software with a Moderate level of concern. MiPACS HTML5 Web Viewer uses web-based technology and a secure operating system. This means that virtually any computer at any location can use an Internet browser to access the device and RIS systems. Whether on-site or from another location, physicians and trained professionals can manage, edit, view and move diagnostic exams quickly and efficiently. As part of the MiPACS HTML5 Web Viewer support, Medicor Imaging, performs virtually all the system maintenance. The MiPACS HTML5 Web Viewer is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities: - . To store and retrieve various kinds of DICOM Objects such as: - -Images from multiple modalities, - -Grayscale Presentation States [GSPS], which specifies the presentations of images as gray scaling, zoom, text and graphical annotations, - -Key Objects [KO], which specifies a particular selection of images for a specified reason and with an attached note, - -Structured Reports [SR]. The MiPACS HTML5 Web Viewer, is a server application. Its Web-based User Interface is intended for system configuration and monitoring by system administrators.
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