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System, Image Management, Ophthalmic

FDA product code NFJ · Class 2 · Radiology

103
Registered devices
47
Adverse events
14
Recalls
53
510(k) clearances

Devices with this code

Ashvins variant Ashvins Diagnostic Workstation — MedicalCommunications GmbHHarmony — TOPCON HEALTHCARE SOLUTIONS, INC.Harmony — TOPCON HEALTHCARE INCEyeSuite Software — Haag-Streit AGHarmony — TOPCON HEALTHCARE INCS4 OPTIK — COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRLScanning Laser Ophthalmoscope — NIDEK CO.,LTD.Merge Eye Care PACS — MERGE HEALTHCARE SOLUTIONS INC.Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web Management — MedicalCommunications GmbHCALLISTO eye — Carl Zeiss Meditec AGHarmony — TOPCON HEALTHCARE SOLUTIONS, INC.Harmony — TOPCON HEALTHCARE INCIRIS — INTELLIGENT RETINAL IMAGING SYSTEMS, LLCCALLISTO eye — Carl Zeiss Meditec AGNA — KONAN MEDICAL, INC.Mydriatic Hyperspectral Retinal Camera — Optina Diagnostiques, IncCANON INC. — CANON INC.Glaucoma Module — TOPCON HEALTHCARE SOLUTIONS, INC.Harmony — TOPCON HEALTHCARE INCAshvins variant Ashvins Diagnostic Workstation — MedicalCommunications GmbHHarmony — TOPCON HEALTHCARE SOLUTIONS, INC.IMAGEnet 6 — TOPCON HEALTHCARE SOLUTIONS, INC.AXIS Image Management System — SONOMED, INC.Harmony — TOPCON HEALTHCARE INC

Recent recalls

DateFirmReason
2025-09-09MedicalCommunications GmbHPotential that the measured value may be smaller than the actual area.
2024-09-17Topcon 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
2022-01-11Diagnos IncRetinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to
2020-12-18Topcon 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
2020-11-03Kowa Optimed IncIt has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the sa
2019-03-06Topcon 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
2017-06-13Merge 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
2017-01-05Haag-Streit USA IncThere is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
2016-04-04Merge Healthcare, Inc.The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
2016-04-04Merge 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

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