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System, Image Management, Ophthalmic
FDA product code NFJ · Class 2 · Radiology
104
Registered devices
48
Adverse events
14
Recalls
53
510(k) clearances
Devices with this code
KOWA VK-2s — KOWA COMPANY,LTD.EyeSuite Software — Haag-Streit AGCANON INC. — CANON INC.IMAGEnet 6 — TOPCON HEALTHCARE SOLUTIONS, INC.Synergy ODM — TOPCON HEALTHCARE INCContinuum PACS — Integrated Ophthalmic Systems, Inc.FORUM — Carl Zeiss Meditec AGHarmony — TOPCON HEALTHCARE SOLUTIONS, INC.iCare ALTIUS CW — CENTERVUE SPAAshvins variant HEYEX 2 / HEYEX PACS — MedicalCommunications GmbHAshvins — MedicalCommunications GmbHCANON INC. — CANON INC.NA — KONAN MEDICAL, INC.Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.Harmony — TOPCON HEALTHCARE INCSynergy ODM — TOPCON HEALTHCARE INCSynergy ODM — TOPCON HEALTHCARE INCCANON INC. — CANON INC.IMAGEnet 6 — TOPCON HEALTHCARE SOLUTIONS, INC.Merge Eye Care PACS — MERGE HEALTHCARE SOLUTIONS INC.Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web Management — MedicalCommunications GmbHCALLISTO eye — Carl Zeiss Meditec AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-09 | MedicalCommunications GmbH | Potential that the measured value may be smaller than the actual area. |
| 2024-09-17 | Topcon Medical Systems, Inc. | The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a |
| 2022-01-11 | Diagnos Inc | Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to |
| 2020-12-18 | Topcon Medical Systems, Inc. | Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient recor |
| 2020-11-03 | Kowa Optimed Inc | It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the sa |
| 2019-03-06 | Topcon Medical Systems, Inc. | When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the p |
| 2017-06-13 | Merge Healthcare, Inc. | When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study in |
| 2017-01-05 | Haag-Streit USA Inc | There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow. |
| 2016-04-04 | Merge Healthcare, Inc. | During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete |
| 2016-04-04 | Merge Healthcare, Inc. | The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. |
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