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510(k) Data Aggregation

    K Number
    K031248
    Device Name
    CONSULTIVA REPORT STATION, MODEL RS-1
    Manufacturer
    MIRAMEDICA, INC
    Date Cleared
    2003-06-20

    (63 days)

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

    MIRAMEDICA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Consultiva™ Report Station is a software application intended to be used to display low resolution, non-diagnostic medical images with annotations such as regions-of-interest or CAD marks.
    Device Description
    The Consultiva™ Report Station (RS) is a Windows-based program that gathers digitized medical images from a specified location on hard disk, and displays those images on a monitor, with Computer Aided Detection (CAD) results (or other annotations) overlaid on top of the images. The RS provides a User Interface (UI) that allows the user to initiate the display of the images . The RS also provides the capability to print a CAD report. The primary data sources for this system include the low resolution digital images and the CAD results. The visualization of CAD and images requires no explicit requirements for user manipulation of the data (zoom, pan, window level, etc). The visualization features of the RS include: The ability to display medical images at a reduced resolution and fixed size. . . The ability to enlarge an image. The ability to display the CAD results as an overlay over the displayed digitized images. .
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