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510(k) Data Aggregation

    K Number
    K152949
    Device Name
    WebPAX
    Manufacturer
    HEART IMAGING TECHNOLOGIES, LLC
    Date Cleared
    2016-08-17

    (316 days)

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

    HEART IMAGING TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations. Due to special customer requirements based on the imaging modality and clinical focus, WebPAX can be configured with different combinations of clinical applications which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques such as multi-planar reconstruction (MPR). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. MPR is not intended for mammography use. Not intended for diagnostic use on mobile devices.
    Device Description
    WebPAX consists of a server, typically located in a hospital data center, and one or more client systems used by technicians and physicians. On the server side, WebPAX is a software-only solution that is installed on customer-supplied hardware, such as dedicated computer server or virtual machine. The server-side software communicates with other DICOM-compliant systems and with end-users via standard Intranet and/or Internet mechanisms. On the client side, technicians and physicians access the WebPAX server using standard Internet web browsers, such as Google Chrome and Internet explorer. WebPAX provides users with the ability to manage, store, and interpret digital medical images, including the following application specific modules: - . Echocardiography Workstation - Cardiovascular MRI Workstation - 3D Post Processing (Multi-Planar Reconstruction)
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    K Number
    K051325
    Device Name
    WEBPAX, MODEL 200
    Manufacturer
    HEART IMAGING TECHNOLOGIES, LLC
    Date Cleared
    2005-06-15

    (26 days)

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

    HEART IMAGING TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use in viewing medical images and making geometric measurements on medical images over the world wide web.
    Device Description
    WebPAX is an integrated software and hardware package capable of communicating and storing medical images. WebPAX provides users with capabilities relating to the transfer, display, and storage of medical images as well as the ability to make geometric measurement of features within the medical images. WebPAX is designed to be deployed over conventional TCP/IP networks and interacts with standard commercially-available computer platforms. WebPAX does not produce any original medical images have been received from DICOM compliant scanners and workstations.
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