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510(k) Data Aggregation

    K Number
    K233925
    Device Name
    Relu Creator
    Manufacturer
    Relu BV
    Date Cleared
    2024-06-13

    (183 days)

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

    Relu BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relu Creator is a software program for the management, transfer, and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.
    Device Description
    The Relu Creator is a software that is part of the digital workflow of dental specialists in preoperative planning. The main purpose is the 3D modeling of the patient anatomy, which is technically called image segmentation and multimodel registration. Based on the model, simulations for preoperative and pretreatment planning can be carried out for dental applications. The 3D modeling (segmentation + registration) is performed on medical images like CBCT, IOS and FS. The preoperative/pretreatment software can be applied in various dental disciplines such as orthodontics, implantology, and maxillofacial surgery.
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