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Found 16 results
510(k) Data Aggregation
K Number
K202948Device Name
EzOrtho
Manufacturer
Ewoo Soft Co., Ltd.
Date Cleared
2020-10-22
(22 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Ewoo Soft Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
Device Description
EzOrtho is a 2D orthodontic analysis and simulation program developed by Ewoosoft. EzOrtho manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms, superimpositions, and VTO (visualised treatment objective) and STO (surgical treatment objective) simulations. The analyzed results are saved in chart format so that the user can easily store and track the treatment and records of each patient.
EzOrtho is designed to provide a simple and straightforward user interface.
- Managing Patients and Registering Images ● EzOrtho offers features for making schedules and managing patient appointments. In addition. EzOrtho enables the users to import images from EzDent-i made by our company, Explorer, or a scanner, and easily calibrate the size of the image or arrange multiple film/photo images.
- . Analyzing and Tracing Images The Landmark Voice Guide and the improved Landmark Input Interface features support easier tracing.
- Establishing Treatment Plans ● The Morphing feature enables the user to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables the user to establish a treatment plan by comparing photos before and after the treatment.
- Assisting with Patient Consultation ● EzOrtho provides features to facilitate understanding and communication between doctors and patients during consultation. For example, the Superimposition feature displays after surgery changes visually, and the Gallery feature plays a slide show with multiple images of patients.
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K Number
K202116Device Name
EzDent-i/ E2/ Prora View/ Smart M Viewer
Manufacturer
Ewoo soft Co., Ltd.
Date Cleared
2020-08-21
(22 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Ewoo soft 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 & K163533 & K173863 & K190791) 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 images by interfacing with X-ray capture software.
EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;
- · Easy and convenient data search function for patient information and clinical images
- · Various image viewing format for 2D dental images
- Various image processing functions including adjustment of brightness and contrast for images
- · Measurement function of length and angle for 2D images
- · Dental implant simulation for treatment planning and effective patient consultation
- · Crown simulation for more effective patient consultation
- · Print function supporting various viewing output format
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K Number
K192888Device Name
EzOrtho
Manufacturer
Ewoo Soft Co., Ltd.
Date Cleared
2020-03-13
(155 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Ewoo Soft Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
Device Description
EzOrtho is a 2D orthodontic analysis program developed by Ewoosoft. EzOrtho manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms, superimpositions, and VTO (visualised treatment objective) and STO (surgical treatment objective). The analyzed results are saved in chart format so that you can easily store and track the treatment and records of each patient.
EzOrtho is designed to provide a simple and straightforward user interface.
- Managing Patients and Registering Images EzOrtho offers powerful features related to making schedules and managing patient appointments. In addition, EzOrtho enables you to import images from EzDenti(K190087, K172364, K163533, K161117, K150747), Explorer, or a scanner and easily calibrate the size of the image or arrange multiple film/photo images.
- . Analyzing and Tracing Images The Landmark Voice Guide and the improved Landmark Input Interface support more accurate and easier tracing.
- . Establishing Treatment Plans The Morphing feature enables you to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables you to establish a treatment plan by comparing photos before and after the treatment.
- . Assisting with Patient Consultation EzOrtho provides features to facilitate understanding and communication between doctors and patients during consultation. For example, the Superimposition feature displays the changes visually due to the treatment and the Gallery feature plays a slide show with multiple images of patients.
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K Number
K190087Device Name
EzDent-i / E2 / Prora View
Manufacturer
EWOO SOFT Co., Ltd.
Date Cleared
2019-02-27
(41 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EWOO SOFT 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 & K163533 & K173863) 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 images by interfacing with X-ray capture software.
EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;
- · Easy and convenient data search function for patient information and clinical images
- · Various image viewing format for 2D dental images
- · Various image processing functions including adjustment of brightness and contrast for images
- · Measurement function of length and angle for 2D images
- · Dental implant simulation for treatment planning and effective patient consultation
- · Crown simulation for more effective patient consultation
- · Print function supporting various viewing output format
Ask a Question
K Number
K173863Device Name
Ez3D-i /E3
Manufacturer
Ewoo Soft Co., Ltd.
Date Cleared
2018-02-23
(65 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Ewoo Soft 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 3dimensional 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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K Number
K173094Device Name
OrthoVision
Manufacturer
Ewoo Soft Co., Ltd.
Date Cleared
2017-10-26
(27 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Ewoo Soft Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Otrho Vision software is indicated for use by orthodontists for image analysis, simulation, profilogram, growth forecast, VTO/STO and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
Device Description
OrthoVision is a 2D orthodontic analysis and simulation program created by EWOOSOFT. OrthoVision manages patient information and images during orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, growth forecasts, profilograms, superimpositions, and VTO/STO simulations. The analyzed results are saved in chart format so that you can easily store and track treatment and records of each patient.
Ask a Question
K Number
K172364Device Name
EzDent-i / E2 / Prora View
Manufacturer
Ewoo Soft Co., Ltd.
Date Cleared
2017-08-22
(18 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Ewoo Soft 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 & K163533) 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 images by interfacing with X-ray capture software.
EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;
- · Easy and convenient data search function for patient information and clinical images
- · Various image viewing format for 2D dental images
- · Various image processing functions including adjustment of brightness and contrast for images
- · Measurement function of length and angle for 2D images
- · Dental implant simulation for treatment planning and effective patient consultation
- · Crown simulation for more effective patient consultation
- · Print function supporting various viewing output format
Ask a Question
K Number
K163533Device Name
EzDent-i; E2; ProraView
Manufacturer
EWOO SOFT CO., LTD.
Date Cleared
2017-01-12
(27 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EWOO SOFT 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) 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 images by interfacing with X-ray capture software.
EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;
- Easy and convenient data search function for patient information and clinical images
- Various image viewing format for 2D dental images
- Various image processing functions including adjustment of brightness and contrast for images
- Measurement function of length and angle for 2D images
- Dental implant simulation for treatment planning and effective patient consultation
- Crown simulation for more effective patient consultation
- Print function supporting various viewing output format
Ask a Question
K Number
K163539Device Name
Ez3D-i / E3
Manufacturer
EWOO SOFT Co., Ltd.
Date Cleared
2016-12-23
(7 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EWOO SOFT 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 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 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.
Ask a Question
K Number
K161246Device Name
Ez3D-i / E3
Manufacturer
EWOO SOFT CO., LTD.
Date Cleared
2016-05-31
(28 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EWOO SOFT 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 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 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
Ask a Question
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