Product code NFJ
- Device name
- System, Image Management, Ophthalmic
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.2050
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234076 | iCare ALTIUS CW | Centervue S.P.A. | 2024-08-22 |
| K232828 | IMAGEnet6 Ophthalmic Data System | Topcon Corporation | 2024-03-01 |
| K232944 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023-12-21 |
| K232555 | Harmony | Topcon Healthcare Solutions | 2023-11-20 |
| K231676 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023-08-28 |
| K232088 | Altris IMS | Altris, Inc. | 2023-07-31 |
| K220929 | Excelsior | Merit Cro, Inc. | 2022-10-31 |
| K213527 | FORUM | Carl Zeiss Meditec, AG | 2022-08-15 |
| K211715 | RetinAI Discovery | Retinai Medical AG | 2022-04-28 |
| K210396 | Harmony Referral System | Topcon Healthcare Solutions EMEA Oy | 2021-09-13 |
| K203244 | CellChek 20 rc | Konan Medical, Inc. | 2021-06-15 |
| K200422 | Image Quality Analyzer (IQA) | Visionquest Biomedical, Inc. | 2020-12-24 |
| K201273 | ImageSPECTRUM | Canon, Inc. | 2020-09-25 |
| K200954 | Glaucoma Module | Topcon Healthcare Solutions, Inc. | 2020-08-03 |
| K200385 | CONTINUUM PACS | Integrated Ophthalmic Systems, Inc. | 2020-03-16 |
| K200275 | OVision Imaging System | Ophthalmic Labs, Inc. | 2020-03-03 |
| K191615 | Huvitz Imaging System | Huvitz Co., Ltd. | 2019-07-18 |
| K190056 | KOWA VK-2s | Kowa Co. Ltd. Chofu | 2019-02-12 |
| K181501 | Afina | Neurovision Imaging, LLC | 2018-11-02 |
| K182318 | Retina Workplace | Carl Zeiss Meditec, Inc. | 2018-10-24 |
| K182376 | Harmony | Topcon Medical Systems, Inc. | 2018-09-28 |
| K181345 | Image Filing Software NAVIS-EX | Nidek Co., Ltd. | 2018-07-19 |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | Welch Allyn, Inc. | 2018-07-16 |
| K180858 | CALLISTO eye | Carl Zeiss Meditec, AG | 2018-06-27 |
| K173689 | Ophthalmic Software Platform RX | Canon Inc. -Medical Equipment Group | 2018-02-23 |
| K171370 | IMAGEnet 6 Ophthalmic Data System | Topcon Corporation | 2017-11-01 |
| K170638 | Retina Workplace | Carl Zeiss Meditec, AG | 2017-06-21 |
| K171098 | AXIS Image Management System | Sonomed, Inc. | 2017-05-02 |
| K161829 | Huvitz Imaging System | Huvitz Co., Ltd. | 2017-04-06 |
| K162039 | OptosAdvance 4.0 Software | Optos Plc. | 2017-02-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08053677040512 | iCare ALTIUS CW | CENTERVUE SPA | 2026-04-29 |
| 06430078740296 | Harmony Referral System | Topcon Healthcare Solutions EMEA Oy | 2026-01-28 |
| 08800019600794 | Huvitz Integrated Image Server HIIS-1 | Huvitz Co., Ltd. | 2025-08-14 |
| 06430078740272 | Harmony Referral System | Topcon Healthcare Solutions EMEA Oy | 2025-08-07 |
| 00850003069500 | Harmony | TOPCON HEALTHCARE INC | 2025-03-04 |
| 00850003069432 | Harmony | TOPCON HEALTHCARE INC | 2025-03-04 |
| 00850003069357 | Harmony | TOPCON HEALTHCARE INC | 2025-03-04 |
| 04260648620084 | Ashvins variant Ashvins Diagnostic Workstation | MedicalCommunications GmbH | 2024-07-09 |
| 04260648620077 | Ashvins variant Ashvins Diagnostic Workstation | MedicalCommunications GmbH | 2024-07-09 |
| 04260648620053 | Ashvins | MedicalCommunications GmbH | 2024-07-09 |
| 04987669200636 | Image filing software NAVIS-EX | NIDEK CO.,LTD. | 2023-06-12 |
| 04987669101568 | Scanning Laser Ophthalmoscope | NIDEK CO.,LTD. | 2023-06-12 |
| 04260648620039 | Ashvins | MedicalCommunications GmbH | 2023-02-24 |
| 04260648620022 | Ashvins | MedicalCommunications GmbH | 2021-08-18 |
| 00627987702125 | Mydriatic Hyperspectral Retinal Camera | Optina Diagnostiques, Inc | 2021-06-07 |
| 00850003069302 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2020-12-09 |
| 04260648620008 | Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web Management | MedicalCommunications GmbH | 2020-12-02 |
| 00850003069241 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2020-06-23 |
| 04260648620015 | Ashvins variant HEYEX 2 / HEYEX PACS | MedicalCommunications GmbH | 2020-03-27 |
| 00850003069203 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-09-19 |
| 00850003069166 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-09-19 |
| 04049539104410 | CALLISTO eye | Carl Zeiss Meditec AG | 2019-08-26 |
| 04049539104403 | CALLISTO eye | Carl Zeiss Meditec AG | 2019-08-21 |
| 00850003069074 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-04-24 |
| 00850003069029 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-02-13 |
| 04562123288582 | IMAGEnet 6 OPHTHALMIC DATA SYSTEM | TOPCON CORPORATION | 2018-02-07 |
| 04549292074345 | CANON INC. | CANON INC. | 2016-09-24 |
| 04049539069092 | CALLISTO eye | Carl Zeiss Meditec AG | 2016-09-22 |
| 08056098470319 | S4 OPTIK | COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL | 2016-09-13 |
| 04987669100523 | Image filing software | NIDEK CO.,LTD. | 2016-08-26 |