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510(k) Data Aggregation

    K Number
    K183695
    Device Name
    OrthoAnalysis Software
    Manufacturer
    Date Cleared
    2019-09-12

    (255 days)

    Product Code
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inteware Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OrthoAnalysis software is designed for use as a medical device providing tools for orthodontic model design and export, inspection, analysis and treatment simulation. The use of the OrthoAnalysis software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
    Device Description
    Not Found
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