FDA Product Code
FDA Product Code NFJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2050
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260694 | ZEISS CLINIC 360 | Carl Zeiss Meditec, AG | 2026-07-17 | Traditional | PDF ↗ |
| K253893 | Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | 2026-06-04 | Traditional | PDF ↗ |
| K234076 | iCare ALTIUS CW | Centervue S.P.A. | 2024-08-22 | Traditional | PDF ↗ |
| K232828 | IMAGEnet6 Ophthalmic Data System | Topcon Corporation | 2024-03-01 | Traditional | PDF ↗ |
| K232944 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023-12-21 | Special | PDF ↗ |
| K232555 | Harmony | Topcon Healthcare Solutions | 2023-11-20 | Special | PDF ↗ |
| K231676 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023-08-28 | Traditional | PDF ↗ |
| K232088 | Altris IMS | Altris, Inc. | 2023-07-31 | Traditional | PDF ↗ |
| K220929 | Excelsior | Merit Cro, Inc. | 2022-10-31 | Traditional | PDF ↗ |
| K213527 | FORUM | Carl Zeiss Meditec, AG | 2022-08-15 | Traditional | PDF ↗ |
| K211715 | RetinAI Discovery | Retinai Medical AG | 2022-04-28 | Traditional | PDF ↗ |
| K210396 | Harmony Referral System | Topcon Healthcare Solutions EMEA Oy | 2021-09-13 | Traditional | PDF ↗ |
| K203244 | CellChek 20 rc | Konan Medical, Inc. | 2021-06-15 | Traditional | PDF ↗ |
| K200422 | Image Quality Analyzer (IQA) | Visionquest Biomedical, Inc. | 2020-12-24 | Traditional | PDF ↗ |
| K201273 | ImageSPECTRUM | Canon, Inc. | 2020-09-25 | Traditional | PDF ↗ |
| K200954 | Glaucoma Module | Topcon Healthcare Solutions, Inc. | 2020-08-03 | Traditional | PDF ↗ |
| K200385 | CONTINUUM PACS | Integrated Ophthalmic Systems, Inc. | 2020-03-16 | Traditional | PDF ↗ |
| K200275 | OVision Imaging System | Ophthalmic Labs, Inc. | 2020-03-03 | Traditional | PDF ↗ |
| K191615 | Huvitz Imaging System | Huvitz Co., Ltd. | 2019-07-18 | Special | PDF ↗ |
| K190056 | KOWA VK-2s | Kowa Co. Ltd. Chofu | 2019-02-12 | Traditional | PDF ↗ |
| K181501 | Afina | Neurovision Imaging, LLC | 2018-11-02 | Traditional | PDF ↗ |
| K182318 | Retina Workplace | Carl Zeiss Meditec, Inc. | 2018-10-24 | Traditional | PDF ↗ |
| K182376 | Harmony | Topcon Medical Systems, Inc. | 2018-09-28 | Special | PDF ↗ |
| K181345 | Image Filing Software NAVIS-EX | Nidek Co., Ltd. | 2018-07-19 | Traditional | PDF ↗ |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | Welch Allyn, Inc. | 2018-07-16 | Traditional | PDF ↗ |
| K180858 | CALLISTO eye | Carl Zeiss Meditec, AG | 2018-06-27 | Traditional | PDF ↗ |
| K173689 | Ophthalmic Software Platform RX | Canon Inc. -Medical Equipment Group | 2018-02-23 | Traditional | PDF ↗ |
| K171370 | IMAGEnet 6 Ophthalmic Data System | Topcon Corporation | 2017-11-01 | Traditional | PDF ↗ |
| K170638 | Retina Workplace | Carl Zeiss Meditec, AG | 2017-06-21 | Traditional | PDF ↗ |
| K171098 | AXIS Image Management System | Sonomed, Inc. | 2017-05-02 | Traditional | PDF ↗ |
| K161829 | Huvitz Imaging System | Huvitz Co., Ltd. | 2017-04-06 | Traditional | PDF ↗ |
| K162039 | OptosAdvance 4.0 Software | Optos Plc. | 2017-02-08 | Traditional | PDF ↗ |
| K151952 | Synergy ODM | Topcon Medical Systems, Inc. | 2015-10-01 | Special | PDF ↗ |
| K150467 | Retina Workplace | Carl Zeiss Meditec, AG | 2015-05-21 | Traditional | PDF ↗ |
| K141922 | IRIS INTELLIGENT RETINAL IMAGING SYSTEM | Intelligent Retinal Imaging Systems, LLC | 2015-02-27 | Traditional | PDF ↗ |
| K141297 | FORUM GLAUCOMA WORKPLACE | Carl Zeiss Meditec, AG | 2014-10-03 | Traditional | PDF ↗ |
| K142423 | EyeSuite Imaging | Haag-Streit AG | 2014-09-10 | Traditional | PDF ↗ |
| K132438 | IMAGENET 5 PC SOFTWARE SYSTEM | Topcon Medical Systems, Inc. | 2013-10-17 | Traditional | PDF ↗ |
| K132667 | SYNERGY ODM | Topcon Medical Systems, Inc. | 2013-10-09 | Traditional | PDF ↗ |
| K130648 | FORUM GLAUCOMA WORKPLACE | Carl Zeiss Meditec, AG | 2013-07-23 | Traditional | PDF ↗ |
| K130453 | EXCELSIOR | Eyekor, LLC | 2013-04-02 | Traditional | PDF ↗ |
| K123464 | CALLISTO EYE | Carl Zeiss Meditec, AG | 2013-03-05 | Traditional | PDF ↗ |
| K122938 | FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH | Carl Zeiss Meditec, AG | 2012-11-02 | Traditional | PDF ↗ |
| K113696 | OPTOS ADVANCE | Optos Plc. | 2012-05-25 | Traditional | PDF ↗ |
| K110869 | CARA | Diagnos, Inc. | 2011-07-14 | Traditional | PDF ↗ |
| K110006 | OIS SYMPHONY IMAGE MANAGMENT SYSTEM | Ophthalmic Imaging Systems | 2011-05-18 | Traditional | PDF ↗ |
| K093313 | SYNERGY | Topcon Medical Systems, Inc. | 2009-12-02 | Traditional | PDF ↗ |
| K090266 | MATCHEDFLICKER | Eyeic Corporation | 2009-05-06 | Traditional | PDF ↗ |
| K090439 | FORUM | Carl Zeiss Meditec, Inc. | 2009-03-25 | Traditional | PDF ↗ |
| K081797 | IMAGE STORAGE SYSTEM, MODEL KSS-400 | Konan Medical, Inc. | 2009-01-22 | Traditional | PDF ↗ |
| K082364 | IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR | Topcon Corp. | 2008-09-30 | Traditional | PDF ↗ |
| K071299 | IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP | Digital Healthcare, Ltd. | 2007-08-31 | Traditional | PDF ↗ |
| K013694 | NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) | Nidek, Inc. | 2002-11-19 | Traditional | PDF ↗ |
Product code NFJ · Class II · Radiology. Data: openFDA.