Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NFJ — Predicate Candidate Screening
53 FDA 510(k) clearances under this product code; the 50 most recent screened below.
107 daysmedian FDA review time
245 days90th percentile
53clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260694 | ZEISS CLINIC 360 | Carl Zeiss Meditec, AG | 2026-07-17 | 136 | 0 |
| K253893 | Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | 2026-06-04 | 182 | 0 |
| K234076 | iCare ALTIUS CW | Centervue S.P.A. | 2024-08-22 | 245 | 0 |
| K232828 | IMAGEnet6 Ophthalmic Data System | Topcon Corporation | 2024-03-01 | 170 | 1 |
| K232944 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023-12-21 | 92 | 0 |
| K232555 | Harmony | Topcon Healthcare Solutions | 2023-11-20 | 89 | 0 |
| K231676 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023-08-28 | 80 | 0 |
| K232088 | Altris IMS | Altris, Inc. | 2023-07-31 | 18 | 0 |
| K220929 | Excelsior | Merit Cro, Inc. | 2022-10-31 | 214 | 0 |
| K213527 | FORUM | Carl Zeiss Meditec, AG | 2022-08-15 | 284 | 0 |
| K211715 | RetinAI Discovery | Retinai Medical AG | 2022-04-28 | 329 | 0 |
| K210396 | Harmony Referral System | Topcon Healthcare Solutions EMEA Oy | 2021-09-13 | 215 | 0 |
| K203244 | CellChek 20 rc | Konan Medical, Inc. | 2021-06-15 | 224 | 0 |
| K200422 | Image Quality Analyzer (IQA) | Visionquest Biomedical, Inc. | 2020-12-24 | 308 | 0 |
| K201273 | ImageSPECTRUM | Canon, Inc. | 2020-09-25 | 136 | 0 |
| K200954 | Glaucoma Module | Topcon Healthcare Solutions, Inc. | 2020-08-03 | 116 | 0 |
| K200385 | CONTINUUM PACS | Integrated Ophthalmic Systems, Inc. | 2020-03-16 | 27 | 0 |
| K200275 | OVision Imaging System | Ophthalmic Labs, Inc. | 2020-03-03 | 28 | 0 |
| K191615 | Huvitz Imaging System | Huvitz Co., Ltd. | 2019-07-18 | 30 | 0 |
| K190056 | KOWA VK-2s | Kowa Co. Ltd. Chofu | 2019-02-12 | 32 | 0 |
| K181501 | Afina | Neurovision Imaging, LLC | 2018-11-02 | 148 | 0 |
| K182318 | Retina Workplace | Carl Zeiss Meditec, Inc. | 2018-10-24 | 58 | 0 |
| K182376 | Harmony | Topcon Medical Systems, Inc. | 2018-09-28 | 28 | 0 |
| K181345 | Image Filing Software NAVIS-EX | Nidek Co., Ltd. | 2018-07-19 | 59 | 0 |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image | Welch Allyn, Inc. | 2018-07-16 | 90 | 0 |
| K180858 | CALLISTO eye | Carl Zeiss Meditec, AG | 2018-06-27 | 86 | 0 |
| K173689 | Ophthalmic Software Platform RX | Canon Inc. -Medical Equipment Group | 2018-02-23 | 84 | 0 |
| K171370 | IMAGEnet 6 Ophthalmic Data System | Topcon Corporation | 2017-11-01 | 175 | 1 |
| K170638 | Retina Workplace | Carl Zeiss Meditec, AG | 2017-06-21 | 111 | 0 |
| K171098 | AXIS Image Management System | Sonomed, Inc. | 2017-05-02 | 19 | 0 |
| K161829 | Huvitz Imaging System | Huvitz Co., Ltd. | 2017-04-06 | 275 | 0 |
| K162039 | OptosAdvance 4.0 Software | Optos Plc. | 2017-02-08 | 201 | 0 |
| K151952 | Synergy ODM | Topcon Medical Systems, Inc. | 2015-10-01 | 78 | 0 |
| K150467 | Retina Workplace | Carl Zeiss Meditec, AG | 2015-05-21 | 87 | 0 |
| K141922 | IRIS INTELLIGENT RETINAL IMAGING SYSTEM | Intelligent Retinal Imaging Systems, LLC | 2015-02-27 | 226 | 0 |
| K141297 | FORUM GLAUCOMA WORKPLACE | Carl Zeiss Meditec, AG | 2014-10-03 | 137 | 0 |
| K142423 | EyeSuite Imaging | Haag-Streit AG | 2014-09-10 | 13 | 0 |
| K132438 | IMAGENET 5 PC SOFTWARE SYSTEM | Topcon Medical Systems, Inc. | 2013-10-17 | 73 | 0 |
| K132667 | SYNERGY ODM | Topcon Medical Systems, Inc. | 2013-10-09 | 43 | 0 |
| K130648 | FORUM GLAUCOMA WORKPLACE | Carl Zeiss Meditec, AG | 2013-07-23 | 134 | 0 |
| K130453 | EXCELSIOR | Eyekor, LLC | 2013-04-02 | 39 | 0 |
| K123464 | CALLISTO EYE | Carl Zeiss Meditec, AG | 2013-03-05 | 116 | 0 |
| K122938 | FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATC | Carl Zeiss Meditec, AG | 2012-11-02 | 39 | 1 |
| K113696 | OPTOS ADVANCE | Optos Plc. | 2012-05-25 | 161 | 0 |
| K110869 | CARA | Diagnos, Inc. | 2011-07-14 | 107 | 0 |
| K110006 | OIS SYMPHONY IMAGE MANAGMENT SYSTEM | Ophthalmic Imaging Systems | 2011-05-18 | 135 | 2 |
| K093313 | SYNERGY | Topcon Medical Systems, Inc. | 2009-12-02 | 41 | 0 |
| K090266 | MATCHEDFLICKER | Eyeic Corporation | 2009-05-06 | 92 | 0 |
| K090439 | FORUM | Carl Zeiss Meditec, Inc. | 2009-03-25 | 33 | 0 |
| K081797 | IMAGE STORAGE SYSTEM, MODEL KSS-400 | Konan Medical, Inc. | 2009-01-22 | 211 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda