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510(k) Data Aggregation

    K Number
    K200704
    Device Name
    ZedView
    Manufacturer
    Lexi Co., Ltd.
    Date Cleared
    2021-05-27

    (435 days)

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

    Lexi Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZedView is indicated for pre-operative planning and post-operative evaluations for various surgical procedures such as artificial joint replacement (arthroplasty), osteotomy, trauma, deformity correction.
    Device Description
    ZedView is a software package that provides computer-assisted 3D planning and evaluations using 2D image data in DICOM or other formats, for various pre-operative surgical procedures and post-operative evaluations. The software is composed of various modules described below.
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    K Number
    K133022
    Device Name
    ZEDVIEW
    Manufacturer
    LEXI CO., LTD.
    Date Cleared
    2014-03-06

    (161 days)

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

    LEXI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZedView is intended to be used to assist qualified medical professionals to perform fast and effective pre-operative planning for various surgical procedures related to hip and knee by using 2D image data. The software is basically intended to be standalone, however some part of the software provides features for communicating with PACS servers to acquire the CT data of various patients or to upload planned projects, images or reports to the servers. ZedView is indicated for pre-operative planning for various surgical procedures related to hip and knee, such as artificial joint replacement (3D templating of implants) and osteotomy.
    Device Description
    ZedView is a software package that provides computer-assisted 3D planning and evaluations using 2D image data in DICOM or other formats, for various pre-operative hip and knee surgical procedures. The software is composed of various modules as shown in Figure 1, below. ZedView is intended to be used to assist qualified medical professionals to perform fast and effective pre-operative planning for various surgical procedures related to hip and knee by using 2D image data. The software is basically intended to be standalone, however some part of the software provides features for communicating with PACS servers to acquire the CT data of various patients or to upload planned projects, images or reports to the servers. The software primarily provides import and storage of CT images of various patients in DICOM or other formats. Also, it provides a means of 3D templating of implants and positioning of fixation devices by calculating surgical parameters in simulated environments and performing 3D measurements on each pre-operative patient data, using 2D image viewing and manipulations, 3D visualizations and various MPR (Multi-Planar Reconstruction) functions. The software also provides separate modules that support pre-operative planning of hip and knee arthroplasty for 2D digital X-rav images obtained with the EOS imaging system by providing quasi-3D templating, 3D measurement, etc. Besides the functional modules for artificial joint replacement surgeries, the software also provides a module that incorporates planning and evaluations for osteotomy (Curved Periacetabular Osteotomy etc.).
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