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510(k) Data Aggregation

    K Number
    K173041
    Device Name
    3DIEMME RealGUIDE
    Manufacturer
    3DIEMME Ltd.
    Date Cleared
    2018-12-20

    (448 days)

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

    3DIEMME Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PC/MAC version: The RealGUIDE software is intended for the following uses: 1. Support to the diagnosis for trained professionals. The input DICOM files acquired by a CT/CBCT scanner are not modified in any way but they are showed to the doctor through the classical imaging and volume rendering techniques. It is a stand-alone product. No information of the patient is modified, all the parameters used for the image processing are read from the DICOM file itself. Neither automatic diagnosis is made, nor automatic disease detection is performed. This software is not connected to any medical instrumentation and it doesn't control any medical or energy supplying device. The user imports DICOM data coming from any CT/CBCT imaging device and the software enables him to view the Patient exam in different multi-planar 2D images and easily reconstruct the 3D volume for an immediate visualization of bone structures and surrounding tissues. 2. Virtual oral and maxillofacial surgery planning. Doctors can plan virtual implants and surgeries on 2D/3D reconstructions and export the projects in open or proprietary format for further processing. The user can choose different implant models (for example dental implants models) from a library provided by the Manufacturers and simulate the positioning in the Patient reconstructed volume (this operation is called "virtual plan") 3. Dental/maxillofacial surgical guides and prosthetic modelling. The virtual plan is used to design a surgical guide that is used by the doctor to drive the surgery drills according to the planned implants direction and depth. This surgical guide can be manufactured by any 3D printer working from STL files. The user can also design the patient (typically a denture) with the surface and volume free-form tools implemented in the result is exported in STL format for 3D printing or CAD/CAM technologies. Mobile version: The RealGUIDE software APP is intended for the following uses: 1. Projects visualization and editing. The input PROJECT files, pre-processed with the RealGUIDE desktop version, are used by trained professionals to evaluate the implants projects, edit them with other colleagues through the cloud, as well as for a more effective Patient treatment communication. The RealGUIDE APP version is NOT INTENDED for managing a 3D diagnosis starting from DICOM images, due to the mobile devices screen resolution limitations. For this reason, the APP is not reading directly the DICOM files but only pre-processed project files, exported through the cloud by the RealGUIDE desktop version.
    Device Description
    RealGUIDE Graphic Station is a fully-featured 3D imaging application in medicine. Its unique open architecture and modular framework make customization options trivial. RealGUIDE Graphic Station is meant to be a multiplatform application, running on PC, MAC and mobile devices (not provided by 3DIEMME). The RealGUIDE software is capable of displaying oral/maxillofacial radiology. The user is then able to navigate through different views, segmented analysis (cross sections), and 3D perspective. In addition, the user is able to simulate various objects within the radiograph for the purpose of treatment planning. Once treatment planning and visual simulation is complete, users can generate reports and simulated images for the purpose of evaluation and diagnosis, as well as perform a surgical guide and prosthesis modelling, to be exported in STL format for the manufacturing with any RP or CAD/CAM machine. The output format of the software is a STL file, mainly focused on dental, maxillofacial and orthognatic surgery. A list of the possible devices that can be modelled with the software is reported below: - -Surgical guides for dental implants and surgical screws planning - -Bone cutting and bone reduction guides for maxillofacial surgery - -Bone graft models for mandible/maxilla regenerative procedures - -Dental and maxillofacial prosthesis
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