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510(k) Data Aggregation

    K Number
    K211480
    Device Name
    NubeX
    Manufacturer
    Date Cleared
    2021-07-08

    (57 days)

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

    TechHeim Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NubeX, PACS is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g physicians, radiologists, nurses, and medical technicians.
    Device Description
    NubeX is a based on the predicated Picture Archiving and Communication system (PACS) device (INFINITT ULite, K163290). NubeX is for displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Among part of image processing, there are different functions than predicated device (INFINITT ULite, K163290). In NubeX, provide image stacking function and 3D cursor function. In case of stacking, after putting the mouse point on an image, you can use the mouse wheel to view the previous or next image of the current one in the series. Stacking shows images within the series. Thus, although the last image currently shows up and the mouse wheel moves down, the last image does not get changed. In case of 3D cursor, after turning on the "3D Cursor" button and selecting an image or stack window, if you use the mouse left button to click and drag on the image, you can see the "X" mark and move the mark to any direction. At that time, you can see the images which are on the mark point in the 3D space. For example, when you click and drag on a sagittal image, you can see the images axial images that are on the mark point in the 3D space. Other than that, the functions basically provided as PACS are the same as those of predicated devices and the additional PACS features don't present any risk to device safety.
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