Other products from "INTRASENSE"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 03700719700433 MYRIAN 2.6 Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. LLZ System, Image Processing, Radiological 2 MYRIAN
2 03700719700471 MYRIAN 2.9 Myrian® is a medical software for processing, management, advanced visualization Myrian® is a medical software for processing, management, advanced visualization, and analysis of multimodality medical images. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including radiologists, surgeons, clinicians and technicians. This device is not indicated for mammography use. LLZ System, Image Processing, Radiological 2 MYRIAN
3 03700719700464 MYRIAN 2.7.6 Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. LLZ System, Image Processing, Radiological 2 MYRIAN
4 03700719700457 MYRIAN 2.8 Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. LLZ System, Image Processing, Radiological 2 MYRIAN
5 03700719700440 MYRIAN 2.7 Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. LLZ System, Image Processing, Radiological 2 MYRIAN
6 03700719700426 MYRIAN 2.5 Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. LLZ System, Image Processing, Radiological 2 MYRIAN
7 03700719700419 MYRIAN 2.4 Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. LLZ System, Image Processing, Radiological 2 MYRIAN
8 03700719700402 MYRIAN 2.3 Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. LLZ System, Image Processing, Radiological 2 MYRIAN
9 03700719700396 MYRIAN 2.2 Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. LLZ System, Image Processing, Radiological 2 MYRIAN
Other products with the same Product Code "LLZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 09358140000024 1.2 SCI0001 Quicktome OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)
2 09358140000017 1.1 SCI0001 Quicktome OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)
3 09351327000848 1.2 1200-0000 OPSInsight™ is intended for use as preoperative surgical planning software to ai OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty. OPSInsight™ OPTIMIZED ORTHO PTY LTD
4 09351327000091 1250-1300 OPS Plan V.2.0 Optimized Positioning System (OPS) Plan OPTIMIZED ORTHO PTY LTD
5 09351327000077 1250-1300 OPS Plan Optimized Positioning System (OPS) Plan OPTIMIZED ORTHO PTY LTD
6 09120105730464 V2.11 The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. KOALA IB LAB GMBH
7 09120105730037 V2.05 The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. KOALA IB LAB GMBH
8 08908008302008 RADSpa RIS-PACS 4.0 RADSpa RIS-PACS RADSpa® TELERAD TECH PRIVATE LIMITED
9 08809466041112 1.2.1.466 QuantorView is an image viewing software dedicated DICOM images produced by imag QuantorView is an image viewing software dedicated DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). QuantorView is a high quality viewing software responsible for displaying PACS image data. It enables physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for researching, teaching, teleconferencing and online collaboration. QuantorView DIGIRAY CORP.
10 08809413810471 ExamVue PACS The ExamVue PACS is a software solution for the storage, sharing, display and vi The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database. Box for ExamVue PACS(outside 265mmx185mmx150mm) JPI HEALTHCARE. CO., LTD.
11 08809413810174 ExamVue PACS The ExamVue PACS is a software solution for the storage, sharing, display and vi The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database. ExamVue JPI HEALTHCARE. CO., LTD.
12 08809278790307 Xelis Dental 2.0 Xelis Dental 2.0 INFINITT HEALTHCARE CO.,LTD.
13 08809278790192 INFINITT RT PACS INFINITT RT PACS INFINITT HEALTHCARE CO.,LTD.
14 08809278790130 INFINITT PACS 7.0 INFINITT PACS INFINITT HEALTHCARE CO.,LTD.
15 08809278790123 INFINITT ULite INFINITT ULite INFINITT HEALTHCARE CO.,LTD.
16 08809278790116 Xelis Dental Xelis Dental INFINITT HEALTHCARE CO.,LTD.
17 08809278790109 Xelis Cardiac Xelis Cardiac INFINITT HEALTHCARE CO.,LTD.
18 08809278790093 Xelis Fusion Xelis Fusion INFINITT HEALTHCARE CO.,LTD.
19 08809278790086 Xelis 3D Xelis 3D INFINITT HEALTHCARE CO.,LTD.
20 08809278790079 Xelis Xelis INFINITT HEALTHCARE CO.,LTD.
21 08809278790062 INFINITT Cardiology PACS INFINITT Cardiology PACS INFINITT HEALTHCARE CO.,LTD.
22 08809278790055 INFINITT PACS INFINITT PACS INFINITT HEALTHCARE CO.,LTD.
23 08809278790000 STARPACS STARPACS INFINITT HEALTHCARE CO.,LTD.
24 08806167789466 USO-U0N5B0K/WR 5D Viewer SAMSUNG MEDISON CO., LTD.
25 08806167761172 USO-U0N5B0B/WR 5D VIEWER SAMSUNG MEDISON CO., LTD.
26 08800086200064 V-B-pAb-02 Veuron-Brain-pAb2 HEURON CO.,LTD.
27 08800086200026 V-B-pAb-01 Veuron-Brain-pAb HEURON CO.,LTD.
28 08800086200019 V-B-mN1-01 Veuron-Brain-mN1 HEURON CO.,LTD.
29 08800046800006 1.1.0 ClariCT.AI CLARIPI INC.
30 08800025300084 1.1 AVIEW LCS CORELINE SOFT CO.,LTD.
31 08800025300077 1.1 AVIEW CORELINE SOFT CO.,LTD.
32 08800025300039 1.0 AVIEW LCS CORELINE SOFT CO.,LTD.
33 08800025300022 1.1 AVIEW Modeler CORELINE SOFT CO.,LTD.
34 08800025300015 1.0 AVIEW CORELINE SOFT CO.,LTD.
35 08800023100006 1.0 OnDemand3DTM CYBERMED INC.
36 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
37 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
38 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
39 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
40 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
41 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
42 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
43 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
44 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
45 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
46 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
47 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
48 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
49 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
50 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