| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00842000100751 | 11.1 | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio V11.1 | ||
| 2 | 00842000100980 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access 8.1 | ||
| 3 | 00842000100027 | 9.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 4 | 00842000100010 | 10.0.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 5 | 00842000100133 | 1.0 | Standalone software application. A universal workflow (non-medical tool) on Merg Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform. | LLZ | System, Image Processing, Radiological | 2 | iConnect Enterprise Workflow with Merge PACS | |
| 6 | 00842000100126 | 6.3 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge iConnect Access | |
| 7 | 00842000100966 | 10.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 8 | 00842000100683 | 6.5 | Stand alone software application. | LLZ | System, Image Processing, Radiological | 2 | iConnect Access | |
| 9 | 00842000100645 | 6.4 | Software application that provides internet access to multi-modality softcopy me Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. | LLZ | System, Image Processing, Radiological | 2 | Merge iConnect Access | |
| 10 | 00842000100447 | 11.0 | Correcting entry. | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | |
| 11 | 00842000100072 | 7.1.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 12 | 00842000100058 | 11.1.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | |
| 13 | 00842000100829 | 13.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | ||
| 14 | 00842000100805 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 15 | 00842000100331 | 11.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | |
| 16 | 00842000100935 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 17 | 00842000100690 | 7.3 | Merge PACS™ is a standards-based medical imaging diagnostic workstation that ser Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians’ worklists and retrieving and managing studies for reading, reporting, communication, and storage.Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.). | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 18 | 00842000100607 | 7.1.0 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 19 | 00842000100560 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 20 | 00842000100508 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 21 | 00842000100478 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 22 | 00842000100461 | 11.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity Pacs | ||
| 23 | 00842000100089 | 7.1.1 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 24 | 00842000100034 | 10.1 | DQK | Computer, Diagnostic, Programmable | 2 | Merge HEMO | ||
| 25 | 00842000100348 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 26 | 00842000100706 | 7.3 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 27 | 00842000100775 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 28 | 00842000100676 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 29 | 00842000100577 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 30 | 00842000100454 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 31 | 00842000100737 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 32 | 00842000100614 | 8.32 | LLZ | System, Image Processing, Radiological | 2 | RadSuite | ||
| 33 | 00842000100515 | 77-00327-00 | Merge Hemo 77-00327-00 Link Assembly | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo Link Assembly | |
| 34 | 00842000100041 | 10.3 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 35 | 00842000100003 | 7.0 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 36 | 90842000100914 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 37 | 00842000100782 | 7.1 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 38 | 00842000100720 | 7.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 39 | 00842000101031 | 6.4 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 40 | 00842000101024 | 9.0 | Correcting entry. | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | |
| 41 | 00842000101017 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 42 | 00842000100928 | 12.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 43 | 00842000100881 | 6.3 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 44 | 00842000100638 | 6.2 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 45 | 00842000100591 | 10.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 46 | 00842000100416 | 11.0 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 47 | 00842000100300 | 4.2.1 | LLZ | System, Image Processing, Radiological | 2 | eFilm Lite | ||
| 48 | 00842000100065 | 2.0 | Stand alone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge Z3D | |
| 49 | 00842000100867 | 4.3 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | eFilm Lite | |
| 50 | 00842000100850 | 4.3 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | eFilm Workstation |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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 | |
| 2 | 00628678950016 | 2.x.y | Version 2.7.0 | densitas® densityAI™ | DENSITAS INCORPORATED | |
| 3 | 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 |
| 4 | 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 | |
| 5 | 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 | |
| 6 | 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 | |
| 7 | 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 | |
| 8 | 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 | |
| 9 | 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 | |
| 10 | 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. | |
| 11 | 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. | |
| 12 | 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. | |
| 13 | 00613994989505 | 9734875 | SFTWR KIT 9734875 StealthViz INT UPGRADE | N/A | MEDTRONIC NAVIGATION, INC. | |
| 14 | 00613994989499 | 9734874 | SFWR KIT 9734874 StealthViz CUST UPGRADE | N/A | MEDTRONIC NAVIGATION, INC. | |
| 15 | 00613994680891 | 9734400XOM | SOFTWARE 9734400XOM STEALTHMERGE ENT PG | N/A | MEDTRONIC NAVIGATION, INC. | |
| 16 | 00613994675750 | 9734400 | SFW KIT 9734400 StealthMerge ENT WITH PG | N/A | MEDTRONIC NAVIGATION, INC. | |
| 17 | 00613994671684 | 9734383 | SFW 9734383 StealthMerge ENT | StealthMerge® ENT | MEDTRONIC NAVIGATION, INC. | |
| 18 | 00613994556127 | 9734108 | SOFTWARE 9734108 StealthViz INT WIN32 | N/A | MEDTRONIC NAVIGATION, INC. | |
| 19 | 00613994555724 | 9734112 | SFTWR KIT 9734112 StealthViz INT WIN32 | StealthViz | MEDTRONIC NAVIGATION, INC. | |
| 20 | 00613994555717 | 9734111 | SFTWR KIT 9734111 StealthViz INT LINUX | StealthViz | MEDTRONIC NAVIGATION, INC. | |
| 21 | 00613994555700 | 9734110 | SFTWR KIT 9734110 STEALTHVIZ WIN32 60DAY | StealthViz | MEDTRONIC NAVIGATION, INC. | |
| 22 | 00613994555694 | 9734109 | SFTWR KIT 9734109 STEALTHVIZ LINUX 60DAY | StealthViz | MEDTRONIC NAVIGATION, INC. | |
| 23 | 00613994555687 | 9734081 | SFTWR KIT 9734081 STEALTHVIZ WIN32 MULTI | StealthViz | MEDTRONIC NAVIGATION, INC. | |
| 24 | 00613994555670 | 9734080 | SFTWR KIT 9734080 STEALTHVIZ LINUX MULTI | StealthViz | MEDTRONIC NAVIGATION, INC. | |
| 25 | 00613994546517 | 9734078 | SFTWR 9734078 STEALTHMERGE S7 PLNG STN | N/A | MEDTRONIC NAVIGATION, INC. | |
| 26 | 00613994521644 | 9734033 | SFTWR KIT 9734033 STEALTHVIZ WIN32 DEMO | StealthViz | MEDTRONIC NAVIGATION, INC. | |
| 27 | 00613994521637 | 9734032 | SFTWR KIT 9734032 STEALTHVIZ LINUX DEMO | Synergy | MEDTRONIC NAVIGATION, INC. | |
| 28 | 00613994515988 | 9734011 | SFTWR 9734011 SYN CRANIAL STEALTHMERGE | StealthMerge | MEDTRONIC NAVIGATION, INC. | |
| 29 | 00613994475930 | 9733979 | SFTWR KIT 9733979 STEALTHVIZ W/DTI WIN32 | StealthViz™ | MEDTRONIC NAVIGATION, INC. | |
| 30 | 00613994453112 | 9733913 | SFTWR KIT 9733913 STEALTHVIZ W/DTI LINUX | StealthViz™ | MEDTRONIC NAVIGATION, INC. | |
| 31 | 00613994446060 | 9733877 | SOFTWARE 9733877 STEALTHVIZ LINUX | N/A | MEDTRONIC NAVIGATION, INC. | |
| 32 | 00613994446053 | 9733878 | SOFTWARE 9733878 STEALTHVIZ WIN32 | N/A | MEDTRONIC NAVIGATION, INC. | |
| 33 | 00613994446039 | 9733902 | LICENSE 9733902 STEALTHVIZ RMA | N/A | MEDTRONIC NAVIGATION, INC. | |
| 34 | 00613994446022 | 9733903 | LICENSE 9733903 STEALTHVIZ | N/A | MEDTRONIC NAVIGATION, INC. | |
| 35 | 00350227500044 | 11.95 | DI DLS | Dolphin Imaging | DOLPHIN IMAGING MGT SOLUTIONS | |
| 36 | 00350227500037 | 11.95 | DI Vers 11.95 PF KYLS | Dolphin Imaging | DOLPHIN IMAGING MGT SOLUTIONS | |
| 37 | 00350227500020 | 11.95 | DI Vers 11.95 PF | Dolphin Imaging | DOLPHIN IMAGING MGT SOLUTIONS | |
| 38 | 00350227500013 | 11.95 | DI Vers 11.95 PRE KYLS | Dolphin Imaging | DOLPHIN IMAGING MGT SOLUTIONS | |
| 39 | 00350227500006 | 11.95 | DI Vers 11.95 PRE | Dolphin Imaging | DOLPHIN IMAGING MGT SOLUTIONS | |
| 40 | 00350227300071 | 1.09 | FUSE version 1.09 | FUSE | PATTERSON TECHNOLOGY CENTER | |
| 41 | 00350227300064 | 1.08 | FUSE version 1.08 | FUSE | PATTERSON TECHNOLOGY CENTER | |
| 42 | 00350227300057 | 1.07 | FUSE version 1.07 | FUSE | PATTERSON TECHNOLOGY CENTER | |
| 43 | 00350227300040 | 1.06 | FUSE version 1.06 | FUSE | PATTERSON TECHNOLOGY CENTER | |
| 44 | 00350227300033 | 1.05 | FUSE version 1.05 | FUSE | PATTERSON TECHNOLOGY CENTER | |
| 45 | 00350227300026 | 1.02 | FUSE version 1.02 | FUSE | PATTERSON TECHNOLOGY CENTER | |
| 46 | 00350227300019 | 1.01 | FUSE version 1.01 | FUSE | PATTERSON TECHNOLOGY CENTER | |
| 47 | 00350227300002 | 1.00 | Fuse version 1.00 | FUSE | PATTERSON TECHNOLOGY CENTER | |
| 48 | 00350227000360 | 21.20 | VOICE EAGLESOFT v21.20 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | |
| 49 | 00350227000353 | 21.20 | LORIN LIBRARY EAGLESOFT v21.20 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | |
| 50 | 00350227000346 | 21.20 | DICOM NETWORK CD EAGLESOFT v21.20 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER |