| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00816847022514 | Perfected Orthopedic Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 2 | 00816847022507 | Resected Autograft Orthopedic Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 3 | 00816847021869 | Allograft Tibia Drilling Guide | A physical guide that is composed of allograft bony anatomy and allows for preci A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 4 | 00816847022491 | Resected Allograft Orthopedic Model | A three dimensional physical model depicting allograft specific modified anatomy A three dimensional physical model depicting allograft specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 5 | 00816847022484 | Resected Patient Orthopedic Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 6 | 00816847022477 | Reconstructed Patient Orthopedic Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 7 | 00816847022460 | Autograft Orthopedic Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 8 | 00816847021883 | Allograft Pelvic Cutting Guide | A physical guide that is composed of allograft bony anatomy and allows for preci A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 9 | 00816847021876 | Allograft Tibia Template | A physical template that is composed of allograft bony anatomy and allows for pr A physical template that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 10 | 00816847022521 | Orthopedic Bone Graft Template | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 11 | 00816847022552 | Orthopedic Bone Osteotomy Template | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 12 | 00816847022545 | Drill Guide (2.7mm and 6.5mm) | Reusable accessory drill guide | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 13 | 00816847022538 | Orthopedic Implant Template | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 14 | 00816847020978 | Plate Bending Template with Predictive Hole Placement | A template that is used as an aide to pre-contour patient’s implants. | LLZ,DZJ | System, Image Processing, Radiological,Driver, Wire, And Bone Drill, Manual | 2 | VSP System | |
| 15 | 00816847022453 | Allograft Orthopedic Model | A three dimensional physical model depicting allograft specific modified anatomy A three dimensional physical model depicting allograft specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 16 | 00816847022446 | Patient Orthopedic Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 17 | 00816847022231 | Autograft Pelvic Template | A physical template that is composed of patient's bony anatomy and allows for pr A physical template that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 18 | 00816847022224 | Autograft Pelvic Drilling Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 19 | 00816847022217 | Autograft Pelvic Marking Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 20 | 00816847022200 | Autograft Pelvic Cutting Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 21 | 00816847022194 | Autograft Tibia Template | A physical template that is composed of patient's bony anatomy and allows for pr A physical template that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 22 | 00816847022187 | Autograft Tibia Drilling Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 23 | 00816847022170 | Autograft Tibia Marking Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 24 | 00816847022163 | Autograft Tibia Cutting Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 25 | 00816847022156 | Autograft Femur Template | A physical template that is composed of patient's bony anatomy and allows for pr A physical template that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 26 | 00816847022149 | Autograft Femur Drilling Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 27 | 00816847022132 | Autograft Femur Marking Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 28 | 00816847022125 | Autograft Femur Cutting Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 29 | 00816847021913 | Allograft Pelvic Template | A physical template that is composed of allograft bony anatomy and allows for pr A physical template that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 30 | 00816847021906 | Allograft Pelvic Drilling Guide | A physical guide that is composed of allograft bony anatomy and allows for preci A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 31 | 00816847021890 | Allograft Pelvic Marking Guide | A physical guide that is composed of allograft bony anatomy and allows for preci A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 32 | 00816847021852 | Allograft Tibia Marking Guide | A physical guide that is composed of allograft bony anatomy and allows for preci A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 33 | 00816847021845 | Allograft Tibia Cutting Guide | A physical guide that is composed of allograft bony anatomy and allows for preci A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 34 | 00816847021838 | Allograft Femur Template | A physical template that is composed of allograft bony anatomy and allows for pr A physical template that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 35 | 00816847021821 | Allograft Femur Drilling Guide | A physical guide that is composed of allograft bony anatomy and allows for preci A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 36 | 00816847021814 | Allograft Femur Marking Guide | A physical guide that is composed of allograft bony anatomy and allows for preci A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 37 | 00816847021807 | Allograft Femur Cutting Guide | A physical guide that is composed of allograft bony anatomy and allows for preci A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 38 | 00816847021593 | Patient Pelvic Template | A physical template that is composed of patient's bony anatomy and allows for pr A physical template that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 39 | 00816847021586 | Patient Pelvic Drilling Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 40 | 00816847021579 | Patient Pelvic Marking Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 41 | 00816847021562 | Patient Pelvic Cutting Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 42 | 00816847021555 | Patient Tibia Template | A physical template that is composed of patient's bony anatomy and allows for pr A physical template that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 43 | 00816847021548 | Patient Tibia Drilling Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 44 | 00816847021531 | Patient Tibia Marking Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 45 | 00816847021524 | Patient Tibia Cutting Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 46 | 00816847021517 | Patient Femur Template | A physical template that is composed of patient's bony anatomy and allows for pr A physical template that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 47 | 00816847021500 | Patient Femur Drilling Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 48 | 00816847021494 | Patient Femur Marking Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 49 | 00816847021487 | Patient Femur Cutting Guide | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | VSP Orthopedics | |
| 50 | 00816847021258 | Resected Mandible Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | LLZ,DZJ | System, Image Processing, Radiological,Driver, Wire, And Bone Drill, Manual | 2 | VSP System |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08806167789466 | USO-U0N5B0K/WR | 5D Viewer | SAMSUNG MEDISON CO., LTD. | ||
| 2 | 08806167761172 | USO-U0N5B0B/WR | 5D VIEWER | SAMSUNG MEDISON CO., LTD. | ||
| 3 | 08800086200064 | V-B-pAb-02 | Veuron-Brain-pAb2 | HEURON CO.,LTD. | ||
| 4 | 08800086200026 | V-B-pAb-01 | Veuron-Brain-pAb | HEURON CO.,LTD. | ||
| 5 | 08800086200019 | V-B-mN1-01 | Veuron-Brain-mN1 | HEURON CO.,LTD. | ||
| 6 | 08800046800006 | 1.1.0 | ClariCT.AI | CLARIPI INC. | ||
| 7 | 08800025300084 | 1.1 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 8 | 08800025300077 | 1.1 | AVIEW | CORELINE SOFT CO.,LTD. | ||
| 9 | 08800025300039 | 1.0 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 10 | 08800025300022 | 1.1 | AVIEW Modeler | CORELINE SOFT CO.,LTD. | ||
| 11 | 08800025300015 | 1.0 | AVIEW | CORELINE SOFT CO.,LTD. | ||
| 12 | 08800023100006 | 1.0 | OnDemand3DTM | CYBERMED INC. | ||
| 13 | 08800022900089 | 1.0 | 1.0 | VARO Plan Software is a stand-alone Windows-based software application to suppor VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry. | VARO Plan | 3D INDUSTRIAL IMAGING CO.,LTD |
| 14 | 08800022900072 | 1.0 | DentiqAir is a software application for the visualization and segmentation of im DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The software is intended to create design outputs to fabricate intraoral mandibular advancement devices used for the reduction of snoring. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. Output of DentiqAir has not been 510(k) cleared yet. The export of the device design file should only be sent to manufacturer who hold a 510(k) for intraoral mandibular advancement devices using DentiqAir software. The manufacture of the device should occur as per the design specifications provided within the 510(k) clearance. | DentiqAir | 3D INDUSTRIAL IMAGING CO.,LTD | |
| 15 | 08800022900041 | 1.0 | DentiqGuide is a software device used to pre-operatively plan the placement of a DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient’s CT image optionally aligned to an optical 3D surface data. Virtual crowns can be used to guide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing. Key Lock. | DentiqGuide | 3D INDUSTRIAL IMAGING CO.,LTD | |
| 16 | 08800022900003 | 1.0 | 1.0 | Dentiq3D is a 3D visualization software for the analysis of various dental CT da Dentiq3D is a 3D visualization software for the analysis of various dental CT data. Dentiq3D provides intuitive and real-time 3D volume processing functions. | Dentiq3D | 3D INDUSTRIAL IMAGING CO.,LTD |
| 17 | 08800019700357 | 3.3 | EzDent-i is dental imaging software that is intended to provide diagnostic tools 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. | EzDent-i | EWOO SOFT CO., LTD | |
| 18 | 08800019700340 | 5.4 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f 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. | Ez3D-i | EWOO SOFT CO., LTD | |
| 19 | 08800019700319 | 1.3 | EzOrtho is a software indicated for use by dentists who provide orthodontic trea 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. | EzOrtho | EWOO SOFT CO., LTD | |
| 20 | 08800019700258 | 1.2 | EzOrtho is a software indicated for use by dentists who provide orthodontic trea 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. | EzOrtho | EWOO SOFT CO., LTD | |
| 21 | 08800019700241 | v1.0 | EzDent Web is a dental imaging software that enables you to save, manage, view a EzDent Web is a dental imaging software that enables you to save, manage, view and process patients’ images. EzDent Web is equipped with management and processing system for various 2D and 3D images. In addition, EzDent Web provides media contents for patient consultation and user friendly instruction to assist your use of the software.EzDent Web provides you with the following functions using patient images in 2D and 3D.- Manage patient information- View patient images in 2D/3D using tools for image processing and view function.- Use high resolution 3D VR to view 3D images in the optimized view for user intent.- Consult patients using media contents provided for patient consultation. | EzDent Web | EWOO SOFT CO., LTD | |
| 22 | 08800019700234 | v5.3 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f 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. | Ez3D-i | EWOO SOFT CO., LTD | |
| 23 | 08800019700227 | v3.2 | EzDent-i is dental imaging software that is intended to provide diagnostic tools 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. | EzDent-i | EWOO SOFT CO., LTD | |
| 24 | 08800019700203 | 1.1 | EzOrtho is a software indicated for use by dentists who provide orthodontic trea 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. | EzOrtho | EWOO SOFT CO., LTD | |
| 25 | 08800019700197 | v3.1 | EzDent-i is dental imaging software that is intended to provide diagnostic tools 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. | EzDent-i | EWOO SOFT CO., LTD | |
| 26 | 08800019700180 | v3.0 | Smart M Viewer(EzDent-i OEM) is medical imaging software that is intended to pro Smart M Viewer(EzDent-i OEM) is medical 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. Smart M Viewer (EzDent-i OEM) 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. | Smart M Viewer | EWOO SOFT CO., LTD | |
| 27 | 08800019700173 | v5.2 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f 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. | Ez3D-i | EWOO SOFT CO., LTD | |
| 28 | 08800019700159 | 1.0 | EzOrtho is a software indicated for use by dentists who provide orthodontic trea 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. | EzOrtho | EWOO SOFT CO., LTD | |
| 29 | 08800019700142 | v1.1 | EzMobile is dental imaging software that is intended to provide diagnostic tools EzMobile 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.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. | EzMobile | EWOO SOFT CO., LTD | |
| 30 | 08800019700128 | v5.1 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f 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. | Ez3D-i | EWOO SOFT CO., LTD | |
| 31 | 08800019700111 | v3.0 | EzDent-i is dental imaging software that is intended to provide diagnostic tools 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. | EzDent-i | EWOO SOFT CO., LTD | |
| 32 | 08800019700098 | v5.0 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f 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. | Ez3D-i | EWOO SOFT CO., LTD | |
| 33 | 08800019700081 | v2.1 | OtrhoVision software is indicated for use by orthodontists for image analysis, s OtrhoVision 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. | OrthoVision | EWOO SOFT CO., LTD | |
| 34 | 08800019700074 | v2.3 | EzDent-i is dental imaging software that is intended to provide diagnostic tools 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. | EzDent-i | EWOO SOFT CO., LTD | |
| 35 | 08800019700067 | v4.3 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f 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. | Ez3D-i | EWOO SOFT CO., LTD | |
| 36 | 08800019700050 | v2.2 | EzDent-i is dental imaging software that is intended to provide diagnostic tools 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. | EzDent-i | EWOO SOFT CO., LTD | |
| 37 | 08800019700036 | v1.2 | Ez3D Plus is dental imaging software that is intended to provide diagnostic tool Ez3D Plus 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 Plus 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. | Ez3D Plus | EWOO SOFT CO., LTD | |
| 38 | 08800019700029 | v2.0 | OtrhoVision software is indicated for use by orthodontists for image analysis, s OtrhoVision 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. | OrthoVision | EWOO SOFT CO., LTD | |
| 39 | 08800019700012 | v4.1 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f 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. | Ez3D-i | EWOO SOFT CO., LTD | |
| 40 | 08800019700005 | v2.1 | EzDent-i is dental imaging software that is intended to provide diagnostic tools 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. | EzDent-i | EWOO SOFT CO., LTD | |
| 41 | 08800018600726 | 2430MCA | 2430MCA is a digital mammography X-ray detector that is based on flat-panel tech 2430MCA is a digital mammography X-ray detector that is based on flat-panel technology. This mammographic image detector and processing unit consists of a CsI scintillator coupled to a CMOS sensor. This device needs to be integrated with a mammographic imaging system. It can be utilized to capture and digitalize X-ray images for mammographic screening. The RAW files can be further processed as DICOM compatible image files by separate console SW, Xmaru W for a mammographic screening. 2430MCA detector is connected by wire to a viewing station via ethernet connection. | 2430MCA | RAYENCE CO., LTD. | |
| 42 | 08800018600610 | XmaruView V1 | XmaruView V1 is a software program designed to provide image acquisition, proces XmaruView V1 is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. XmaruView V1 performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. XmaruView V1 provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography. | XmaruView V1 | RAYENCE CO., LTD. | |
| 43 | 08800018600603 | Xmaru Chiroview | Xmaru Chiroview is a software program designed to provide image acquisition, pro Xmaru Chiroview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Chiroview performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. Xmaru Chiroview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography. | Xmaru Chiroview | RAYENCE CO., LTD. | |
| 44 | 08800018600597 | Xmaru Podview | Xmaru Podview is a software program designed to provide image acquisition, proce Xmaru Podview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Podview performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. Xmaru Podview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography. | Xmaru Podview | RAYENCE CO., LTD. | |
| 45 | 08800018600580 | Xmaru Pro | Xmaru Pro software carries out the image processing and administration of medica Xmaru Pro software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, measurements, automated measurement of bone age from a child's hand X-ray, and function to assist the image reading by detecting abnormal areas on the chest X-ray. Xmaru Pro is complying with DICOM standards to assure optimum communications between network systems. (not approved for mammography) Xmaru Pro offered as a stand-alone imaging solution to be installed in a PC for trained medical professionals. | Xmaru Pro | RAYENCE CO., LTD. | |
| 46 | 08800018600573 | ClearON Mobile | ClearON Mobile provides easy touch based user interface to perform diagnosis of ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database. It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment. | ClearON Mobile | RAYENCE CO., LTD. | |
| 47 | 08800018600429 | Xmaru PACS | Xmaru PACS is a software program designed to provide image acquisition, processi Xmaru PACS is a software program designed to provide image acquisition, processing and operational management functions for Digital Radiography. | Xmaru PACS | RAYENCE CO., LTD. | |
| 48 | 08800018600399 | XmaruView V1 | XmaruView V1 is a radiographic image acquisition and image data management progr XmaruView V1 is a radiographic image acquisition and image data management program in charge of variety of image related functions, including photographing Digital Radiography, acquiring and processing the images, and the image management | XmaruView V1 | RAYENCE CO., LTD. | |
| 49 | 08800018411001 | 1.0 | The Rconsole1 is intended for use with mammographic images acquired using digita The Rconsole1 is intended for use with mammographic images acquired using digital breast x-ray systems. | RConsole1 | DRTECH CORPORATION | |
| 50 | 08800018410004 | 1.0 | The Econsole1 is indicated for use in general radiographic images of human anatomy. | EConsole1 | DRTECH CORPORATION |