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510(k) Data Aggregation

    K Number
    K210726
    Device Name
    ImmersiveTouch
    Date Cleared
    2021-09-29

    (202 days)

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

    ImmersiveTouch, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ImmersiveTouch is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. ImmersiveTouch is also intended for measuring and treatment planning. ImmersiveTouch output can be used for the fabrication of physical replicas of the output file using traditive manufacturing methods. The physical replicas generated from digital output files are not for diagnostic purpose. ImmersiveTouch should be used in conjunction with expert clinical judgment.
    Device Description
    ImmersiveTouch is a stand-alone modular software package that allows user to import, visualize and segment medical images to create accurate 3D representations. The 3D models can be utilized in ImmersiveTouch for measuring, treatment planning and output file to be further used as an input for additive manufacturing. This modular package includes, but is not limited to the following functions: - Importing medical images in DICOM format for visualization, segmentation, and analysis. - Viewing of medical imaging data in the axial. coronal and sagittal views. - Calculating a digital 3D model and editing the model. - Measurements on 3D models. - Treatment Planning on 3D models with cutting planes and the ability to move cut objects. - File export for 3D Printing.
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