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510(k) Data Aggregation

    K Number
    K171068
    Device Name
    OrthoView 7.2
    Date Cleared
    2017-10-18

    (191 days)

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

    Meridian Technique Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OrthoView is indicated for use when a suitable licensed and qualified healthcare professional requires access to medical images with the intention of using such images to plan or review a surgical procedure. OrthoView provides a set of tools and templates (representing prosthetic and fixation devices) to assist the healthcare professional in planning their surgery. The device is not to be used for mammography.
    Device Description
    OrthoView 7.2 is dedicated, digital, pre-operative planning and templating software used to create detailed pre-operative plans quickly and easily from digital x-ray images. OrthoView 7.2 is software to be used for medical purposes, performing these purposes without being part of a hardware medical device. The device provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.
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