| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04571130283152 | NW500 | HKI | Camera, ophthalmic, ac-powered | 2 | NON-MYDRIATIC RETINAL CAMERA NW500 | ||
| 2 | 04571130282612 | MEASURING HEAD CONNECTION CABLE(14m) for COMPU VISION CV-5000 | HKN | Refractor, Manual, Non-Powered, Including Phoropter | 1 | MEASURING HEAD CONNECTION CABLE(14m) for COMPU VISION CV-5000 | ||
| 3 | 04562123288247 | SL-D8Z | HJO | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 2 | SLIT LAMP SL-D8Z | ||
| 4 | 04562123289046 | DRI OCT Triton(plus) | HKI,OBO | Camera, ophthalmic, ac-powered,Tomography, optical coherence | 2 | 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plus) | ||
| 5 | 04562123288230 | SL-D8Z | HJO | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 2 | SLIT LAMP SL-D8Z | ||
| 6 | 04562123285239 | SO-FT02 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | EXTERNAL FIXATION TARGET SO-FT02 for SLIT LAMP SL-2G | ||
| 7 | 04562123283327 | OBSERVATION TUBE | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | OBSERVATION TUBE | ||
| 8 | 04562123280265 | FIXATION TARGET | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | FIXATION TARGET | ||
| 9 | 04571130283015 | POWER SUPPLY UNIT for CV-5000 | HKN | Refractor, Manual, Non-Powered, Including Phoropter | 1 | POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE) | ||
| 10 | 04562123288292 | TRC-NW8F(plus) | HKI | Camera, ophthalmic, ac-powered | 2 | NON-MYDRIATIC RETINAL CAMERA TRC-NW8F(plus) | ||
| 11 | 04562123288254 | TRC-NW8 | HKI | Camera, ophthalmic, ac-powered | 2 | NON-MYDRIATIC RETINAL CAMERA TRC-NW8 | ||
| 12 | 04562123286441 | TL-5A | HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 1 | TL-5A | ||
| 13 | 04562123283495 | SO-AS3 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | AUXILIARY SPRING SO-AS3 | ||
| 14 | 04562123283334 | BEAM SPLITTER | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | BEAM SPLITTER | ||
| 15 | 04562123280531 | PRISM COMPENSATOR for LENSMETER LM-8 | HLM | Instrument, Measuring, Lens, Ac-Powered | 1 | PRISM COMPENSATOR for LENSMETER LM-8 | ||
| 16 | 04560126264640 | INFRARED COMMUNICATION UNIT | HKN | Refractor, Manual, Non-Powered, Including Phoropter | 1 | INFRARED COMMUNICATION UNIT | ||
| 17 | 04562123289817 | BG-5 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | BACKGROUND ILLUMINATION BG-5 | ||
| 18 | 04562123289749 | BG-2GN | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | BACKGROUND ILLUMINATION BG-2GN | ||
| 19 | 04562123289596 | SL-D701 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D701 | ||
| 20 | 04562123289565 | SL-D4 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D4 | ||
| 21 | 04562123289558 | SL-D4 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D4 | ||
| 22 | 04562123288698 | POWER SUPPLY UNIT for CV-5000 | HKN | Refractor, Manual, Non-Powered, Including Phoropter | 1 | POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE) | ||
| 23 | 04562123288582 | IMAGEnet 6 | HKI,OBO,NFJ | Camera, Ophthalmic, Ac-Powered,Tomography, Optical Coherence,System, image manag Camera, Ophthalmic, Ac-Powered,Tomography, Optical Coherence,System, image management, ophthalmic | 2 | IMAGEnet 6 OPHTHALMIC DATA SYSTEM | ||
| 24 | 04562123288285 | SL-D701 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D701 | ||
| 25 | 04562123288223 | SL-D7 | HJO | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 2 | SLIT LAMP SL-D7 | ||
| 26 | 04562123288216 | SL-D7 | HJO | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 2 | SLIT LAMP SL-D7 | ||
| 27 | 04562123284959 | SL-D4 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D4 | ||
| 28 | 04562123282856 | SL-D4 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D4 | ||
| 29 | 04560126266071 | KR-1W Viewer | HKO | Refractometer, Ophthalmic | 1 | KR-1W Viewer | ||
| 30 | 04571130283084 | PC-50S | HOX | Chart, Visual Acuity | 1 | PIXELCHART PC-50S for COMPU VISION CV-5000 | ||
| 31 | 04562123289848 | TL-211 | HKI | Camera, ophthalmic, ac-powered | 2 | TV RELAY LENS ADAPTER TL-211 for RETINAL CAMERA TRC-50DX | ||
| 32 | 04562123289718 | SO-DFL01 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | DIFFUSION LENS SO-DFL01 for SLIT LAMP SL-D301 | ||
| 33 | 04562123289039 | DRI OCT Triton | HKI,OBO | Camera, ophthalmic, ac-powered,Tomography, optical coherence | 2 | 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton | ||
| 34 | 04562123286502 | MS-BS03-50/50 | HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 1 | BEAM SPLITTER MS-BS03-50/50 | ||
| 35 | 04562123283488 | SO-AS2 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | AUXILIARY SPRING SO-AS2 | ||
| 36 | 04562123283310 | OBSERVATION TUBE + BEAM SPLITTER | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | OBSERVATION TUBE + BEAM SPLITTER | ||
| 37 | 04562123289831 | PB-2 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | PARALLEL BINOCULAR TUBE PB-2 | ||
| 38 | 04571130283060 | MC-5S | HOX | Chart, Visual Acuity | 1 | MIRROR CHART MC-5S for COMPU VISION CV-5000 | ||
| 39 | 04571130283039 | KR-800S | HKO | Refractometer, Ophthalmic | 1 | AUTO KERATO-REFRACTOMETER KR-800S | ||
| 40 | 04571130282520 | Chronos | HKO | Refractometer, Ophthalmic | 1 | REFRACTION SYSTEM Chronos | ||
| 41 | 04562123289732 | DIFFUSER | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | DIFFUSER for SLIT LAMP SL-D2, SLIT LAMP SL-D4, SLIT LAMP SL-D4(Type:LED) | ||
| 42 | 04562123289572 | SL-D301 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D301 | ||
| 43 | 04562123289206 | ACP-8 | HOS | Projector, Ophthalmic | 1 | AUTO CHART PROJECTOR ACP-8 | ||
| 44 | 04562123288605 | 3D OCT-1 | OBO,HKI | Tomography, optical coherence,Camera, ophthalmic, ac-powered | 2 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 | ||
| 45 | 04562123288322 | 3D OCT-1 | HKI,OBO | Camera, ophthalmic, ac-powered,Tomography, optical coherence | 2 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 | ||
| 46 | 04562123288315 | SP-1P | NQE | Microscope, specular | 2 | SPECULAR MICROSCOPE SP-1P | ||
| 47 | 04562123288131 | SL-D301 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | SLIT LAMP SL-D301 | ||
| 48 | 04562123283624 | INTERNAL FIXATION TARGET MOUNT | HKI | Camera, ophthalmic, ac-powered | 2 | INTERNAL FIXATION TARGET MOUNT for RETINAL CAMERA TRC-50DX | ||
| 49 | 04562123283471 | SO-AS1 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | AUXILIARY SPRING SO-AS1 | ||
| 50 | 04562123289763 | SO-LED01 | HJO | Biomicroscope, slit-lamp, ac-powered | 2 | LED UNIT SO-LED01 for SLIT LAMP SL-D701 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00842000100584 | 5.1.4 | Standalone software application | Merge Eye Care PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 2 | 00842000100553 | 5.1.1 Patch 1 | Standalone software application | Merge Eye Care PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 3 | 00842000100317 | 5.3 | Standalone software application | Merge Eye Care PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 4 | 00842000100140 | 11.6.1 | Merge Eye Station | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 5 | 00842000100096 | 5.2 | Standalone software application | Merge Eye Care PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 6 | 00627987702125 | MHRC-C1 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Mydriatic Hyperspectral Retinal Camera | OPTINA DIAGNOSTIQUES, INC | |
| 7 | B543CAR0 | Version 4 | CARA is an innovative software program that uses enhanced digital images to supp CARA is an innovative software program that uses enhanced digital images to support and identify the early detection of vision loss and more specifically diabetic retinopathy. CARA is a teleophthalmology platform which includes advanced retinal imaging technology and clinical grading services by eye care professionals. | CARA | DIAGNOS INC | |
| 8 | 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 | |
| 9 | 08056098470319 | COBRA | 103303A00 V0/S10 | COBRA FUNDUS CAMERA | S4 OPTIK | COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL |
| 10 | 07640132987256 | i9.0 | EyeSuite Software | HAAG-STREIT AG | ||
| 11 | 07640132986105 | i8.2 | EyeSuite Software | HAAG-STREIT AG | ||
| 12 | 05057056905709 | S90570 | OPTOS ADVANCE | OPTOS PUBLIC LIMITED COMPANY | ||
| 13 | 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. | |
| 14 | 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. | |
| 15 | 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. | |
| 16 | 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. | |
| 17 | 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. | |
| 18 | 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. | |
| 19 | 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. | |
| 20 | 04582275250657 | CC 20 rc | NA | KONAN MEDICAL, INC. | ||
| 21 | 04582275250428 | Cellchek | NA | KONAN MEDICAL, INC. | ||
| 22 | 04562123288582 | IMAGEnet 6 | IMAGEnet 6 OPHTHALMIC DATA SYSTEM | TOPCON CORPORATION | ||
| 23 | 04562123288308 | IMAGEnet 5 | IMAGEnet 5 OPHTHALMIC DATA SYSTEM | TOPCON CORPORATION | ||
| 24 | 04549292182729 | imageSPECTRUM | CANON INC. | CANON INC. | ||
| 25 | 04549292084696 | Ophthalmic Software Platform RX | CANON INC. | CANON INC. | ||
| 26 | 04549292074345 | CX-1 | CANON INC. | CANON INC. | ||
| 27 | 04260648620022 | 2021 (Build 1920) | Ashvins | MEDICALCOMMUNICATIONS GMBH | ||
| 28 | 04260648620015 | 2.5 | Ashvins variant HEYEX 2 / HEYEX PACS | MEDICALCOMMUNICATIONS GMBH | ||
| 29 | 04260648620008 | Ashvins 2020 | Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web Management | MEDICALCOMMUNICATIONS GMBH | ||
| 30 | 04049539104410 | 3.7 | CALLISTO eye | CARL ZEISS MEDITEC AG | ||
| 31 | 04049539104403 | 3.6.2 | CALLISTO eye | CARL ZEISS MEDITEC AG | ||
| 32 | 04049539104366 | CALLISTO eye | CALLISTO eye | CARL ZEISS MEDITEC AG | ||
| 33 | 04049539102423 | 3.2.1 | CALLISTO eye | CARL ZEISS MEDITEC AG | ||
| 34 | 04049539069092 | 3.5.1 | CALLISTO eye | CARL ZEISS MEDITEC AG | ||
| 35 | 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 | |
| 36 | 04049471070200 | 1 | FORUM ASSIST match | CARL ZEISS MEDITEC AG | ||
| 37 | 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 | |
| 38 | 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 | |
| 39 | 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 | |
| 40 | 03615020000496 | ANAEYES OCT | ANAEYES OCT for system linkage | ESSILOR INTERNATIONAL | ||
| 41 | 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. |
| 42 | 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 | |
| 43 | 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. | |
| 44 | 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. | |
| 45 | 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. | |
| 46 | 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. | |
| 47 | 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. | |
| 48 | 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. | |
| 49 | 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. | |
| 50 | 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. |