| 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 | 00842000100409 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 14 | 00842000100829 | 13.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | ||
| 15 | 00842000100805 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 16 | 00842000100331 | 11.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | |
| 17 | 00842000100935 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 18 | 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 | |
| 19 | 00842000100607 | 7.1.0 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 20 | 00842000100560 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 21 | 00842000100508 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 22 | 00842000100478 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 23 | 00842000100461 | 11.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity Pacs | ||
| 24 | 00842000100089 | 7.1.1 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 25 | 00842000100034 | 10.1 | DQK | Computer, Diagnostic, Programmable | 2 | Merge HEMO | ||
| 26 | 00842000100348 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 27 | 00842000100706 | 7.3 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 28 | 00842000100775 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 29 | 00842000100676 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 30 | 00842000100577 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 31 | 00842000100454 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 32 | 00842000100737 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 33 | 00842000100614 | 8.32 | LLZ | System, Image Processing, Radiological | 2 | RadSuite | ||
| 34 | 00842000100515 | 77-00327-00 | Merge Hemo 77-00327-00 Link Assembly | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo Link Assembly | |
| 35 | 00842000100041 | 10.3 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 36 | 00842000100003 | 7.0 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 37 | 90842000100914 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 38 | 00842000100782 | 7.1 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 39 | 00842000100720 | 7.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 40 | 00842000101031 | 6.4 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 41 | 00842000101024 | 9.0 | Correcting entry. | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | |
| 42 | 00842000101017 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 43 | 00842000100928 | 12.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 44 | 00842000100881 | 6.3 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 45 | 00842000100638 | 6.2 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 46 | 00842000100591 | 10.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 47 | 00842000100416 | 11.0 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 48 | 00842000100300 | 4.2.1 | LLZ | System, Image Processing, Radiological | 2 | eFilm Lite | ||
| 49 | 00842000100065 | 2.0 | Stand alone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge Z3D | |
| 50 | 00842000100867 | 4.3 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | eFilm Lite |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08906096520069 | Remidio Connect | Remidio Connect is web-based application it is intended for displaying, storing Remidio Connect is web-based application it is intended for displaying, storing images and data from Remidio ophthalmic imaging devices to aid in screening of eye disease. | Remidio | REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED | |
| 2 | 08056098470319 | COBRA | 103303A00 V0/S10 | COBRA FUNDUS CAMERA | S4 OPTIK | COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL |
| 3 | 07640132987256 | i9.0 | EyeSuite Software | HAAG-STREIT AG | ||
| 4 | 07640132986105 | i8.2 | EyeSuite Software | HAAG-STREIT AG | ||
| 5 | 05057056905709 | S90570 | OPTOS ADVANCE | OPTOS PUBLIC LIMITED COMPANY | ||
| 6 | 04987669101421 | 1.0 | Data Acquisition Service for NAVIS-EX (hereafter referred to as DAS) acquires da Data Acquisition Service for NAVIS-EX (hereafter referred to as DAS) acquires data from measurement devices and transfers it to NAVIS-EX.In addition to acquisition of measurement data, DAS registers patients newly registered with the ALScan/CEM-530 to NAVIS-EX. | Data Acquisition Service for NAVIS-EX | NIDEK CO.,LTD. | |
| 7 | 04987669101360 | 1.1 | The AL-Scan Viewer for NAVIS-EX software (hereafter referred to as AL-Scan Viewe The AL-Scan Viewer for NAVIS-EX software (hereafter referred to as AL-Scan Viewer) is used to handle the AL-Scan data within NAVIS-EX. This function is added to the computer as a plug-in for NAVISEX. The measured value data and waveform can be displayed, the IOL power can be calculated, andthe toric lens assist data can be created. The AL-Scan data is imported to NAVIS-EX using separate software, Data Acquisition Service. | AL-Scan Viewer for NAVIS-EX | NIDEK CO.,LTD. | |
| 8 | 04987669101353 | 1.1 | The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is us The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the examination data of the SPECULAR MICROSCOPE CEM-530 or use the data for follow-up within IMAGE FILING SOFTWARE NAVIS-EX. This function is added to the computer as a plug-in for NAVIS-EX. The examination data is displayed, analyzed, and used for follow-up. CEM Viewer can be used to display examination data on the Viewer screen or follow up data on the Follow-Up screen. The examination data is saved and managed within NAVIS-EX. The CEM Viewer data is imported to NAVIS-EX using separate software, Data Acquisition Service for NAVIS-EX. | CEM Viewer for NAVIS-EX | NIDEK CO.,LTD. | |
| 9 | 04987669100523 | NAVIS-EX | The NAVIS-EX image filing software is software that acquires data from the follo The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the clientPC. | Image filing software | NIDEK CO.,LTD. | |
| 10 | 04987646808947 | VK28U2E | KOWA VK-2s is indicated for acquiring, displaying and storing image data from KO KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras. | KOWA VK-2s | KOWA COMPANY,LTD. | |
| 11 | 04987646808930 | VK28UE | KOWA VK-2s is indicated for acquiring, displaying and storing image data from KO KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras. | KOWA VK-2s | KOWA COMPANY,LTD. | |
| 12 | 04987646808923 | VK28K | KOWA VK-2s is indicated for acquiring, displaying and storing image data from KO KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras. | KOWA VK-2s | KOWA COMPANY,LTD. | |
| 13 | 04582275250657 | CC 20 rc | NA | KONAN MEDICAL, INC. | ||
| 14 | 04582275250428 | Cellchek | NA | KONAN MEDICAL, INC. | ||
| 15 | 04562123288582 | IMAGEnet 6 | IMAGEnet 6 OPHTHALMIC DATA SYSTEM | TOPCON CORPORATION | ||
| 16 | 04562123288308 | IMAGEnet 5 | IMAGEnet 5 OPHTHALMIC DATA SYSTEM | TOPCON CORPORATION | ||
| 17 | 04549292182729 | imageSPECTRUM | CANON INC. | CANON INC. | ||
| 18 | 04549292084696 | Ophthalmic Software Platform RX | CANON INC. | CANON INC. | ||
| 19 | 04549292074345 | CX-1 | CANON INC. | CANON INC. | ||
| 20 | 04260648620022 | 2021 (Build 1920) | Ashvins | MEDICALCOMMUNICATIONS GMBH | ||
| 21 | 04260648620015 | 2.5 | Ashvins variant HEYEX 2 / HEYEX PACS | MEDICALCOMMUNICATIONS GMBH | ||
| 22 | 04260648620008 | Ashvins 2020 | Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web Management | MEDICALCOMMUNICATIONS GMBH | ||
| 23 | 04049539104410 | 3.7 | CALLISTO eye | CARL ZEISS MEDITEC AG | ||
| 24 | 04049539104403 | 3.6.2 | CALLISTO eye | CARL ZEISS MEDITEC AG | ||
| 25 | 04049539104366 | CALLISTO eye | CALLISTO eye | CARL ZEISS MEDITEC AG | ||
| 26 | 04049539102423 | 3.2.1 | CALLISTO eye | CARL ZEISS MEDITEC AG | ||
| 27 | 04049539069092 | 3.5.1 | CALLISTO eye | CARL ZEISS MEDITEC AG | ||
| 28 | 04049471100037 | 1.4.1 | This database entry covers UDI for SW Versions 1.4.1 and higher: (01)04049471000 This database entry covers UDI for SW Versions 1.4.1 and higher: (01)04049471000037(10)150-> Version 1.5 | FORUM ASSIST match | CARL ZEISS MEDITEC AG | |
| 29 | 04049471070200 | 1 | FORUM ASSIST match | CARL ZEISS MEDITEC AG | ||
| 30 | 04049471070118 | 1.0 | This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118 This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6 | Retina Workplace | CARL ZEISS MEDITEC AG | |
| 31 | 04049471070101 | 2.0 | This database entry covers UDI for SW Versions 2.0 and higher (Glaucoma Workplac This database entry covers UDI for SW Versions 2.0 and higher (Glaucoma Workplace): (01)04049471070101(10)310 -> Version 3.1, (01)04049471070101(10)311 -> Version 3.1.1, (01)04049471070101(10)350 -> Version 3.5 | FORUM Glaucoma Workplace | CARL ZEISS MEDITEC AG | |
| 32 | 04049471070026 | 4.1 | This database entry covers UDI for SW Versions 4.1 and higher: (01)0404947107002 This database entry covers UDI for SW Versions 4.1 and higher: (01)04049471070026(10)411 -> Version 4.1.1; (01)04049471070026(10)420 -> Version 4.2; (01)04049471070026(10)421 -> Version 4.2.1; (01)04049471070026(10)423 -> Version 4.2.3; (01)04049471070026(10)424 -> Version 4.2.4, (01)04049471070026(10)425 -> Version 4.2.5, (01)04049471070026(10)426 -> Version 4.2.6 | FORUM | CARL ZEISS MEDITEC AG | |
| 33 | 03615020000496 | ANAEYES OCT | ANAEYES OCT for system linkage | ESSILOR INTERNATIONAL | ||
| 34 | 00896100002002 | Ver 5 | Axis | Software application for ophthalmic image management system with a browser-based Software application for ophthalmic image management system with a browser-based interface for image review and analysis of ophthalmic images. Software utilizing available data from ophthalmic devices to provide views and tools that are clinically useful in helping to diagnose and monitor. A picture archiving and communication system to allow storage, retrieval, analysis, and management of digital images of the eye. Provides integration of different ophthalmic devices for any imaging modality. Complaint with DICOM interoperability standard and can integrate any DICOM-compliant device, including using DICOM modality worklists. Axis can integrate non-DICOM devices to provide data and imaging regardless of device type. Can be integrated with any EHR system via HL7 interface or other means. Functionality and access to images can be from AXIS server or AXIS cloud. | AXIS Image Management System | SONOMED, INC. |
| 35 | 00860001130508 | 3.0 | The IRIS software is a software as a service application that is hosted on the i The IRIS software is a software as a service application that is hosted on the internet which allows clinicians the ability to scan a patient's retina with a fundus camera,transmit the images up to a website and offer an opinion on the scans. It also allows users the ability to input data relative to a visual fields exam. | IRIS | INTELLIGENT RETINAL IMAGING SYSTEMS, LLC | |
| 36 | 00852683007049 | 4.09 | Synergy ODM 4.09 is a comprehensive software platform intended for use in import Synergy ODM 4.09 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Synergy ODM | TOPCON MEDICAL SYSTEMS, INC. | |
| 37 | 00852683007032 | 4.08 | Synergy ODM 4.08 is a comprehensive software platform intended for use in import Synergy ODM 4.08 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Synergy ODM | TOPCON MEDICAL SYSTEMS, INC. | |
| 38 | 00852683007025 | 4.07 | Synergy ODM 4.07 is a comprehensive software platform intended for use in import Synergy ODM 4.07 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Synergy ODM | TOPCON MEDICAL SYSTEMS, INC. | |
| 39 | 00852683007018 | 4.06 | Synergy ODM 4.06 is a comprehensive software platform intended for use in import Synergy ODM 4.06 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Synergy ODM | TOPCON MEDICAL SYSTEMS, INC. | |
| 40 | 00852683007001 | 4.05 | Synergy ODM 4.05 is a comprehensive software platform intended for use in import Synergy ODM 4.05 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Synergy ODM | TOPCON MEDICAL SYSTEMS, INC. | |
| 41 | 00850003069302 | 2.4.0 | The IMAGEnet 6 ver. 2.4.0 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.4.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 42 | 00850003069296 | 5.06.003 | Harmony 5.06.003 is a comprehensive software platform intended for use in import Harmony 5.06.003 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Harmony | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 43 | 00850003069289 | 5.06.002 | Harmony 5.06.002 is a comprehensive software platform intended for use in import Harmony 5.06.002 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Harmony | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 44 | 00850003069265 | 5.07 | Harmony 5.07 is a comprehensive software platform intended for use in importing, Harmony 5.07 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Harmony | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 45 | 00850003069241 | 2.3.0 | The IMAGEnet 6 ver. 2.3.0 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.3.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 46 | 00850003069234 | 5.05.102 | Harmony 5.05.102 is a comprehensive software platform intended for use in import Harmony 5.05.102 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Harmony | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 47 | 00850003069227 | 5.05.101 | Harmony 5.05.101 is a comprehensive software platform intended for use in import Harmony 5.05.101 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Harmony | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 48 | 00850003069203 | 2.2.1 | The IMAGEnet 6 ver. 2.2.1 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.2.1 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices. | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 49 | 00850003069197 | 5.05.100 | Harmony 5.05.100 is a comprehensive software platform intended for use in import Harmony 5.05.100 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Harmony | TOPCON HEALTHCARE SOLUTIONS, INC. | |
| 50 | 00850003069180 | 5.04.200 | Harmony 5.04.200 is a comprehensive software platform intended for use in import Harmony 5.04.200 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. | Harmony | TOPCON HEALTHCARE SOLUTIONS, INC. |