Other products from "MEVIS MEDICAL SOLUTIONS AG"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 04260483290114 2.3 LLZ System, Image Processing, Radiological 2 DynaCAD Lung
2 04260483290053 2.2 LLZ System, Image Processing, Radiological 2 DynaCAD Lung
3 04260483290046 1.3 OEB Lung Computed Tomography System, Computer-Aided Detection 2 Veolity LungCAD
4 04260483290060 2.2 OEB Lung Computed Tomography System, Computer-Aided Detection 2 DynaCAD Lung Server
5 04260483290183 2.4 2.4.0.229939, Release date: 2021-09-032.4.1.252491, Release date: 2022-03-25 OEB,LLZ Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological 2 DynaCAD Lung
6 04260483290121 2.3 2.3.0.224889, Release date: 2017-12-132.3.1.239548, Release date: 2019-10-01 OEB Lung Computed Tomography System, Computer-Aided Detection 2 DynaCAD Lung Server
7 04260483290107 1.4 OEB Lung Computed Tomography System, Computer-Aided Detection 2 Veolity LungCAD
8 04260483290169 3.2 LLZ System, Image Processing, Radiological 2 DynaSuite Neuro
9 04260483290015 5.7 OEB Lung Computed Tomography System, Computer-Aided Detection 2 Visia LungCAD
10 04260483290084 5.8 5.8.0.224889, Release date: 2017-12-135.8.1.246755, Release date: 2020-12-01 OEB Lung Computed Tomography System, Computer-Aided Detection 2 Visia LungCAD
11 04260483290091 1.4 LLZ System, Image Processing, Radiological 2 Veolity
12 04260483290039 1.3 LLZ System, Image Processing, Radiological 2 Veolity
13 04260483290176 1.7 1.7.0.228241, Release date: 2021-03-181.7.1.252491, Release date: 2022-03-25 OEB,LLZ Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological 2 Veolity
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19 00628914000017 eUnity-1 eUnity software is a diagnostic medical imaging display workstation. As part of eUnity software is a diagnostic medical imaging display workstation. As part of an EMR, Portal or as a stand-alone application, eUnity provides secure access to full-fidelity DICOM images with unprecedented performance using nothing more than a common web-browser (no client software to manage.) Medical professionals can now access medical images across multiple sites and multiple PACS using eUnity as their image viewing platform. eUnity CLIENT OUTLOOK INC
20 00628678950016 2.x.y Version 2.7.0 densitas® densityAI™ DENSITAS INCORPORATED
21 00628451892021 1 P008943 The Halifax Imaging Kit is part of the SR Suite product line, provides an altern The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path tocreating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Raycomponents integrated into an existing digital radiography room already containing an FDAcleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kitand the existing DR system are synchronized by replacing the trigger switches of the twosystems with the Halifax Synchronization Switch. The Halifax Synchronization Switchensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray imagesfrom two different perspectives to be taken at the exact same time. This process allows forRoentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR).RSA is a stereo x-ray technique that enables measurements more accurate and precise thansingle plane radiography based on phantom studies. The increased level of precision enablesmeasurement of implant stability. Halifax Imaging Kit HALIFAX BIOMEDICAL INCORPORATED
22 00628105001762 7.6 EasyViz is a diagnostic software image display workstation that has the ability EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers a simple and fast access to diagnostic quality imaging information when and where needed by Radiologists, Cardiologists, Clinicians and referring Physicians. EasyViz CANON MEDICAL INFORMATICS A/S
23 00628105001755 7.5 EasyViz is a diagnostic software image display workstation that has the ability EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologists, Cardiologists, Clinicians and referring Physicians. EasyViz CANON MEDICAL INFORMATICS A/S
24 00628105001748 7.4 EasyViz is a diagnostic software image display workstation that has the ability EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologists, Cardiologists, Clinicians and referring Physicians. EasyViz CANON MEDICAL INFORMATICS A/S
25 00628105001731 7.3 EasyViz is a diagnostic software image display workstation that has the ability EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologist, Cardiologists, Clinicians and referring Physicians. EasyViz CANON MEDICAL INFORMATICS A/S
26 00628055858010 2.0 Fusion Bx 2.0 is designed to display the 2D live video received from commerciall Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure. Fusion Bx FOCAL HEALTHCARE INC
27 00628055858003 1.1 Fusion Bx is designed to display the 2D live video received from commercially av Fusion Bx is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. The device will assist clinicians in planning and performing image-guided interventional procedures such as biopsies and placing instruments in the prostate for adult men with suspected prostate cancer.Fusion Bx is comprised of a laptop-based workstation and a hardware assembly. The included hardware consists of a frame grabber, encoder converter, hardware arm (comprising of a swing arm, counterbalance, tracker and stepper), and stand. The stepper holds the ultrasound probe and measures probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. Encoders in the stepper and tracker send joint movement information to the computer workstation which tracks probe position and orientation. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Fusion Bx. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate and to display the live image position within the prostate. Fusion Bx FOCAL HEALTHCARE INC
28 00628011382160 1.6.0 Limbus Contour is a stand-alone software medical device. It is a single purposes Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). Limbus Contour LIMBUS AI INC.
29 00628011382153 1.5.0 Limbus Contour is a stand-alone software medical device. It is a single purposes Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). Limbus Contour LIMBUS AI INC.
30 00628011382146 1.4.0 Limbus Contour is a stand-alone software medical device. It is a single purposes Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files). Limbus Contour LIMBUS AI INC.
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