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510(k) Data Aggregation

    K Number
    K073272
    Device Name
    WORKSTATIONONE BREAST IMAGING WORKSTATION
    Manufacturer
    THREE PALM SOFTWARE, LLC
    Date Cleared
    2007-12-11

    (20 days)

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

    THREE PALM SOFTWARE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WorkstationOne™ Breast Imaging Workstation is intended for use with a regionally approved digital mammography system. The workstation displays images from multiple modalities, which include X-ray mammography MG, breast US and breast MRI. The workstation allows selection, display, manipulation, quantification, markup, print composition and media exchange of breast images. Here, quantification refers to measurements (such as area and distance) within a region of interest that the radiologist manually draws on the images. Similarly, markup refers to graphics that are manually drawn by the radiologist to indicate a region of interest. Note that the region of interest is not automatically generated by the computer. The WorkstationOne™ Breast Imaging Workstation is intended for softcopy reading and interpretation of digital mammography images by Radiologists. The WorkstationOne™ Breast Imaging Workstation when used for interpretation of images acquired using a FFDM image acquisition system shall display the images only on FDA-cleared high-resolution monitors. The images used for primary diagnostic reading must be in a lossless format, unless lossy formats are approved for use in digital mammography.
    Device Description
    The WorkstationOne™ is a diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation also supports media exchange and film printing. Optionally, the workstation can interface with a reporting system to generate an interpretation report. The enterprise workflow of the workstation follows IHE integration profiles, specifically, MAMMO (Mammography Image Profile) and RWP (Reporting Workflow Profile). The workstation can be configured to use mammographic specific hanging protocol and reading workflow. The workstation obtains the source images and CAD reports either as the recipient of the push of that data, or by querying and retrieving them from a PACS archive. In both models, DICOM is used. The images can only be the lossless compressed or non-compressed DICOM images. The WorkstationOne™ is a software system that can be installed on an off-the-shelf general-purpose computer with one or two aray-scale high-resolution monitors and one color monitor. The high-resolution monitors are used to display digital mammography images and associated overlays for the purpose of primary interpretation by radiologists. The color monitor is used for selecting studies, displaying color images, navigating workflow, and other user interface elements. Optionally, a dedicated keypad or touchpad is included for ergonomic reasons.
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