System, Image Management, Ophthalmic
FDA product code NFJ · Class II (moderate risk) · 21 CFR 892.2050 · Radiology
53510(k) clearances
0PMA approvals
14recalls
Manufacturers
- Carl Zeiss Meditec, AG 13
- Topcon Medical Systems, Inc. 5
- Topcon Corporation 3
- Topcon Healthcare Solutions 2
- Konan Medical, Inc. 2
- Topcon Healthcare Solutions EMEA Oy 2
- Optos Plc. 2
- Nidek, Inc. 2
- Huvitz Co., Ltd. 2
- Eyekor, LLC 1
- Kowa Co. Ltd. Chofu 1
- Neurovision Imaging, LLC 1
- Centervue S.P.A. 1
- Canon Inc. -Medical Equipment Group 1
- Sonomed, Inc. 1
- Intelligent Retinal Imaging Systems, LLC 1
- Haag-Streit AG 1
- Diagnos, Inc. 1
- Ophthalmic Imaging Systems 1
- Eyeic Corporation 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260694 | Zeiss Clinic 360NFJ · Traditional | Carl Zeiss Meditec, AG | 07/17/2026SE |
| K253893 | Harmony Referral System with Harmony OCT Viewer (Octave)NFJ · Traditional | Topcon Healthcare Solutions EMEA Oy | 06/04/2026SE |
| K234076 | iCare ALTIUS CWNFJ · Traditional | Centervue S.P.A. | 08/22/2024SE |
| K232828 | IMAGEnet6 Ophthalmic Data SystemNFJ · Traditional | Topcon Corporation | 03/01/2024SE |
| K232944 | CALLISTO eyeNFJ · Special | Carl Zeiss Meditec, AG | 12/21/2023SE |
| K232555 | HarmonyNFJ · Special | Topcon Healthcare Solutions | 11/20/2023SE |
| K231676 | CALLISTO eyeNFJ · Traditional | Carl Zeiss Meditec, AG | 08/28/2023SE |
| K232088 | Altris IMSNFJ · Traditional | Altris, Inc. | 07/31/2023SE |
| K220929 | ExcelsiorNFJ · Traditional | Merit Cro, Inc. | 10/31/2022SE |
| K213527 | ForumNFJ · Traditional | Carl Zeiss Meditec, AG | 08/15/2022SE |
| K211715 | RetinAI DiscoveryNFJ · Traditional | Retinai Medical AG | 04/28/2022SE |
| K210396 | Harmony Referral SystemNFJ · Traditional | Topcon Healthcare Solutions EMEA Oy | 09/13/2021SE |
| K203244 | CellChek 20 rcNFJ · Traditional | Konan Medical, Inc. | 06/15/2021SE |
| K200422 | Image Quality Analyzer (IQA)NFJ · Traditional | Visionquest Biomedical, Inc. | 12/24/2020SE |
| K201273 | ImageSPECTRUMNFJ · Traditional | Canon, Inc. | 09/25/2020SE |
| K200954 | Glaucoma ModuleNFJ · Traditional | Topcon Healthcare Solutions, Inc. | 08/03/2020SE |
| K200385 | Continuum PacsNFJ · Traditional | Integrated Ophthalmic Systems, Inc. | 03/16/2020SE |
| K200275 | OVision Imaging SystemNFJ · Traditional | Ophthalmic Labs, Inc. | 03/03/2020SE |
| K191615 | Huvitz Imaging SystemNFJ · Special | Huvitz Co., Ltd. | 07/18/2019SE |
| K190056 | KOWA VK-2sNFJ · Traditional | Kowa Co. Ltd. Chofu | 02/12/2019SE |
| K181501 | AfinaNFJ · Traditional | Neurovision Imaging, LLC | 11/02/2018SE |
| K182318 | Retina WorkplaceNFJ · Traditional | Carl Zeiss Meditec, Inc. | 10/24/2018SE |
| K182376 | HarmonyNFJ · Special | Topcon Medical Systems, Inc. | 09/28/2018SE |
| K181345 | Image Filing Software NAVIS-EXNFJ · Traditional | Nidek Co., Ltd. | 07/19/2018SE |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemNFJ · Traditional | Welch Allyn, Inc. | 07/16/2018SE |
| K180858 | CALLISTO eyeNFJ · Traditional | Carl Zeiss Meditec, AG | 06/27/2018SE |
| K173689 | Ophthalmic Software Platform RXNFJ · Traditional | Canon Inc. -Medical Equipment Group | 02/23/2018SE |
| K171370 | IMAGEnet 6 Ophthalmic Data SystemNFJ · Traditional | Topcon Corporation | 11/01/2017SE |
| K170638 | Retina WorkplaceNFJ · Traditional | Carl Zeiss Meditec, AG | 06/21/2017SE |
| K171098 | AXIS Image Management SystemNFJ · Traditional | Sonomed, Inc. | 05/02/2017SE |
| K161829 | Huvitz Imaging SystemNFJ · Traditional | Huvitz Co., Ltd. | 04/06/2017SE |
| K162039 | OptosAdvance 4.0 SoftwareNFJ · Traditional | Optos Plc. | 02/08/2017SE |
| K151952 | Synergy ODMNFJ · Special | Topcon Medical Systems, Inc. | 10/01/2015SE |
| K150467 | Retina WorkplaceNFJ · Traditional | Carl Zeiss Meditec, AG | 05/21/2015SE |
| K141922 | Iris Intelligent Retinal Imaging SystemNFJ · Traditional | Intelligent Retinal Imaging Systems, LLC | 02/27/2015SE |
| K141297 | Forum Glaucoma WorkplaceNFJ · Traditional | Carl Zeiss Meditec, AG | 10/03/2014SE |
| K142423 | EyeSuite ImagingNFJ · Traditional | Haag-Streit AG | 09/10/2014SE |
| K132438 | Imagenet 5 PC Software SystemNFJ · Traditional | Topcon Medical Systems, Inc. | 10/17/2013SE |
| K132667 | Synergy OdmNFJ · Traditional | Topcon Medical Systems, Inc. | 10/09/2013SE |
| K130648 | Forum Glaucoma WorkplaceNFJ · Traditional | Carl Zeiss Meditec, AG | 07/23/2013SE |
| K130453 | ExcelsiorNFJ · Traditional | Eyekor, LLC | 04/02/2013SE |
| K123464 | Callisto EyeNFJ · Traditional | Carl Zeiss Meditec, AG | 03/05/2013SE |
| K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist MatchNFJ · Traditional | Carl Zeiss Meditec, AG | 11/02/2012SE |
| K113696 | Optos AdvanceNFJ · Traditional | Optos Plc. | 05/25/2012SE |
| K110869 | CaraNFJ · Traditional | Diagnos, Inc. | 07/14/2011SE |
| K110006 | Ois Symphony Image Managment SystemNFJ · Traditional | Ophthalmic Imaging Systems | 05/18/2011SE |
| K093313 | SynergyNFJ · Traditional | Topcon Medical Systems, Inc. | 12/02/2009SE |
| K090266 | MatchedflickerNFJ · Traditional | Eyeic Corporation | 05/06/2009SE |
| K090439 | ForumNFJ · Traditional | Carl Zeiss Meditec, Inc. | 03/25/2009SE |
| K081797 | Image Storage System, Model KSS-400NFJ · Traditional | Konan Medical, Inc. | 01/22/2009SE |
| K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…NFJ · Traditional | Topcon Corp. | 09/30/2008SE |
| K071299 | Ip System, Oculab Ip, Optomize Ip, Retasure IpNFJ · Traditional | Digital Healthcare, Ltd. | 08/31/2007SE |
| K013694 | Nidek Advanced Vision Information System (Navis)NFJ · Traditional | Nidek, Inc. | 11/19/2002SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2673-2025 Class II | Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to…Potential that the measured value may be smaller than the actual area. | MedicalCommunications GmbH | 09/09/2025Open, Classified |
| Z-0362-2025 Class II | The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in…The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called… | Topcon Medical Systems, Inc. | 09/17/2024Open, Classified |
| Z-0826-2022 Class II | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179Retinal analysis system software has some features, based on artificial intelligence, that potentially lack… | Diagnos Inc | 01/11/2022Terminated |
| Z-0952-2021 Class II | Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage:…Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of… | Topcon Medical Systems, Inc. | 12/18/2020Terminated |
| Z-0636-2021 Class II | Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa…It has been determined that the software distributed with the retinal camera may delete patient information.… | Kowa Optimed Inc | 11/03/2020Terminated |
| Z-1138-2019 Class II | IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is…When a patient is selected in the patient data and another patient is selected prior to the display of the… | Topcon Medical Systems, Inc. | 03/06/2019Terminated |
| Z-2754-2017 Class II | Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the…When the user has not set up any user preference on the sorting order to render the study images… | Merge Healthcare, Inc. | 06/13/2017Terminated |
| Z-1500-2017 Class II | EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular…There is a possibility for data to be stored under the wrong patient on the DICOM Server following a… | Haag-Streit USA Inc | 01/05/2017Terminated |
| Z-1828-2017 Class II | Merge Eye Station and Merge Eye Care PACS.During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a… | Merge Healthcare, Inc. | 04/04/2016Terminated |
| Z-1681-2017 Class II | Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge…The system will completely stop allowing the downloading or acquisition of new images due to incompatible… | Merge Healthcare, Inc. | 04/04/2016Terminated |
| Z-1246-2017 Class II | Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye…Eye Station images were not importing properly and were imported under "unknown" due to an issue when… | Merge Healthcare, Inc. | 03/28/2016Terminated |
| Z-1049-2015 Class II | FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and…Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical… | Carl Zeiss Meditec AG | 01/22/2015Terminated |
| Z-1664-2010 | Bausch & Lomb Stellaris Vision Enhancement System.The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain… | Bausch & Lomb Inc | 01/15/2010Terminated |
| Z-1663-2010 | Bausch & Lomb Millennium Microsurgical System.The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain… | Bausch & Lomb Inc | 01/15/2010Terminated |