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510(k) Data Aggregation

    K Number
    K220649
    Device Name
    Elucis
    Date Cleared
    2023-01-17

    (316 days)

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

    Realize Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Elucis is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended for measuring and treatment planning. Elucis should be used in conjunction with expert clinical judgement.
    Device Description
    Elucis is a software system for creating, visualizing, and interacting with three-dimensional (3D) models in a desktop 2D environment and an extended (virtual) reality (XR) environment. Medical images (e.g., CT and MRI) and, optionally, 3D structure files in a variety of file formats are used as input. Users can create 3D anatomical models directly from one or more medical images using a variety of manual and semi-automatic image segmentation tools available in the XR environment. These models, and the images from which they were created, can be used to conduct measurements and plan treatments. The core functionality in Elucis includes the ability to: - View medical images in a variety of planar and volumetric reformations - Import medical images in DICOM and other formats and import 3D model files - Create 3D models from medical images using a variety of common modeling tools - Review and edit existing 3D models - Perform measurements on images and models - Plan treatments using 3D models and associated medical images - Save and export images, measurements, 3D models, and other treatment planning information
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