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510(k) Data Aggregation

    K Number
    K082336
    Device Name
    XR-EXPRESS
    Date Cleared
    2008-10-15

    (62 days)

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

    NEW MEXICO SOFTWARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    XR-EXpress is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. XR-EXpress is for hospitals, imaging centers, nursing homes, radiologist reading practices, and any user who requires and is granted access to patient image, demographic, and report information. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
    Device Description
    The XR-EXpress system is comprised of a capture component (XR-EXpress Capture), a central server component (XR-EXpress Server), and a viewer component (XR-EXpress Viewer) that is used on general purpose computing hardware. Patient information, procedure information, and image acquisition data is captured by XR-EXpress Capture and sent to the XR-EXpress server or alternatively, it is accepted directly from a DICOM compliant device. After receiving image objects and associated data, the XR-EXpress server registers the incoming data and images with the archive including any associations with prior cases. The cases are presented to users with the correct permissions from a work list as controlled by a managing user. The image data is transmitted and rendered on the users workstation using a standard web browser for management views or the XR-EXpress Viewer for diagnosis. After using the workstation to view the images, the user optionally dictates a report into the system, after which, a user can play back the dictation and transcribe it to text. Once the XR-EXpress Server registers a report, the report is available to the referring physician or client service where it available electronically or via fax.
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