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    K Number
    K190767
    Device Name
    AnatomicAligner
    Manufacturer
    The Methodist Hospital Research Institute d/b/a Houston
    Date Cleared
    2020-03-16

    (357 days)

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

    The Methodist Hospital Research Institute d/b/a Houston

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AnatomicAligner is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as CT or MRI, in patients who have reached sketal and dental maturity.
    Device Description
    AnatomicAligner is an image-processing software with a user-friendly interface for pre-operative simulation of orthognathic surgical treatment options based on imaging information from a medical scanner such as CT or MRI. The software planning results may be transferred to surgery.
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