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510(k) Data Aggregation

    K Number
    K212981
    Device Name
    MirrorMe3D Modeling System
    Manufacturer
    Date Cleared
    2022-04-22

    (217 days)

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

    MirrorMe3D, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MirrorMe3D Modeling System is intended for use as an image processing system for the transfer of 3D medical images. The MirrorMe3D Modeling System is also intended as a visualization system for measuring and treatment planning for aesthetic facial soft tissue. The input data is processed by the System using off-the-shelf modeling software and the result is an output data file that may then be provided as a digital model or used as input for the additive manufacturing of a physical anatomic model, which is not for diagnostic use. The MirrorMe3D Modeling System should only be used in conjunction with expert clinical judgment and is not intended for diagnostic use. MirrorMe3D trained personnel will use off-the-shelf software to assist users in creating the 3D virtual (or digital) model that depicts the surgeon's intended outcome. The anatomic models are not for diagnostic use.
    Device Description
    The MirrorMe3D Modeling System is image processing software that enables the input and visualization of 3D medical imaging with output files that can be virtual or physical 3D anatomic models. The Modeling System software is used for visualization of preoperative treatment planning options, with measurement functionality, for surgery of the aesthetic facial soft tissue.
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