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510(k) Data Aggregation

    K Number
    K032401
    Device Name
    ORTHOVIEW
    Manufacturer
    OMSBAR LTD
    Date Cleared
    2003-08-14

    (10 days)

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

    OMSBAR LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthoview™ is indicated for use when a suitably licensed and qualified healthcare professional requires access to medical images with the intention of using such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
    Device Description
    Orthoview™ is a software device that permits the orthopedic surgeon to pre-plan surgical procedures by permitting image viewing and manipulation and prosthetic template overlay within a PACS workstation or standalone environment.
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