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510(k) Data Aggregation

    K Number
    K241114
    Device Name
    EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)
    Manufacturer
    EwooSoft Co., Ltd.
    Date Cleared
    2024-07-23

    (92 days)

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

    EwooSoft Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
    Device Description
    EzDent-i v3.5 is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment. EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616, K150761, K161246, K163539, K173863, K190791, K200178, K211791, K222069, K231757) but the EzDent-i itself does not view, transfer or process 3D radiographs. EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor /Intra-Oral Scanner images by interfacing with Xray capture software.
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    K Number
    K211795
    Device Name
    EzDent-i/ E2/ Prora View/ Smart M Viewer
    Manufacturer
    Ewoosoft Co., Ltd.
    Date Cleared
    2021-10-04

    (116 days)

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

    Ewoosoft Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
    Device Description
    EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment. EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616, K150761, K161246, K163539, K173863, K190791, K200178) but the EzDent-i itself does not view, transfer or process 3D radiographs. EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor /Intra-Oral Scanner images by interfacing with Xray capture software.
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    K Number
    K200178
    Device Name
    Ez3D-i /E3
    Manufacturer
    Ewoosoft Co., Ltd.
    Date Cleared
    2020-02-25

    (32 days)

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

    Ewoosoft Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
    Device Description
    Ez3D-i is 3D viewing software for prompt and accurate diagnosis dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3-dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc for the benefit of effective doctor and patient communication and precise treatment planning. Ez3D-i is a useful tool for an easier diagnosis and analysis by processing a 3D image with simple and convenient user interface.
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    K Number
    K192098
    Device Name
    EzMobile
    Manufacturer
    Ewoosoft Co., Ltd.
    Date Cleared
    2020-01-20

    (168 days)

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

    Ewoosoft Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EzMobile is dental imaging software that is intended to provide various tools for maxillofacial radiographic imaging. These tools are available to view a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzMobile is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
    Device Description
    EzMobile is dental imaging software that is intended to provide various tools for maxillofacial radiographic imaging. These tools are available to view a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzMobile is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
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    K Number
    K190791
    Device Name
    Ez3D-i/E3
    Manufacturer
    EwooSoft Co., Ltd.
    Date Cleared
    2019-04-19

    (23 days)

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

    EwooSoft Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
    Device Description
    Ez3D-i is 3D viewing software for prompt and accurate diagnosis dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3 dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc for the benefit of effective doctor and patient communication and precise treatment planning. Ez3D-i is a useful tool for an easier diagnosis and analysis by processing a 3D image with simple and convenient user interface. Ez3D-i's main functions are; - · Image adaptation through various rendering methods such as Teeth/Bone/Soft tissue/MIP - · Versatile 3D image viewing via MPR Rotating, Curve mode - · "Sculpt" for deleting unnecessary parts to view only the region of interest. - · Implant Simulation for efficient treatment planning and effective patient consultation - · Canal Draw to trace alveolar canal and its geometrical orientation relative to teeth. - · "Bone Density" test to measure bone density around the site of an implant(s) - · Various utilities such as Measurement, Annotation, Gallery, and Report - · 3D Volume function to transform the image into 3D Panorama and the Tab has been optimized for Implant Simulation. - . Provides the Axial View of TMJ, the Condyle/Fossa images in 3D and the Section images, and supports functions to separate the Condyle/Fossa and display the bone density - · STO/VTO Simulation to predict orthodontic treatment/ surgery results with 3D Photo image. - · Segmentation function to get tooth segmentation data from CT, label each segmented tooth data as an object and utilize them in simulation such as tooth extraction, implant simulation, etc.
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