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510(k) Data Aggregation

    K Number
    K052424
    Device Name
    MAXILIM
    Manufacturer
    MEDICIM NV
    Date Cleared
    2006-03-31

    (210 days)

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

    MEDICIM NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Maxilim is indicated for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for surgical treatment, specifically maxillofacial procedures.
    Device Description
    The device is a software device (minor level of concern) with minimal risk to the patient. The device does not make contact with the patient. The device is used to assist physicians in the planning of surgical treatments, but is not meant to replace the professional judgment of the physician.
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