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510(k) Data Aggregation

    K Number
    K141669
    Device Name
    SURGIMAP
    Manufacturer
    NEMARIS INC
    Date Cleared
    2014-09-19

    (88 days)

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

    NEMARIS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgimap software assists healthcare professionals in viewing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap users. Clinical judgment and experience are required to properly use the software.
    Device Description
    Surgimap is software developed for the medical community. It is intended to be used to view, store and transport images as well as perform generic or specialty measurements and plan or simulate aspects of surgical procedures. The image formats supported encompasses the standard image formats (jpeg, tiff, png, ....) and also DICOM images. Images can be stored in the Surgimap database and measurements (generic or specialty specific) can be overlaid to each image. Surgimap also offers the ability for the end user to plan, or simulate, aspects of certain surgical procedures such as osteotomies and templating implants (including but not limited to screws, interbody cages, rods). Via internet connection during use of the software application, the database can be synchronized online. An optional feature consists in organizing patient information into cases with the possibility to share these cases among Surgimap users.
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    K Number
    K111019
    Device Name
    SURGIMAP (TM) SPINE
    Manufacturer
    NEMARIS INC
    Date Cleared
    2011-09-30

    (171 days)

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

    NEMARIS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgimap Spine software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as spine related measurements of the images, to plan surgical procedures (osteotomies), and includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.
    Device Description
    Surgimap Spine is a software solution developed for the medical community. It is intended to be used to view, store, and transport images as well as perform spine related measurements and plan surgical procedures. The image formats supported encompass the standard image formats (jpeg, tiff, png, ....) and also the DICOM images. Images can be stored in a database and measurements (generic or spine specific) can be overlaid to each image. Surgimap Spine also offers the ability for the end user to plan certain surgical procedures such as osteotomies of the spine and templating generic implants (screws and interbody cages). SurgiSmap Spine is a standalone application developed for windows environment. Surgimap Spine can be downloaded directly from www.surgimap.com via the Internet and run off a digital storage such as USB or personal computer hard drive
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