CEM Viewer for NAVIS-EX
NIDEK CO.,LTD. · Model 1.1 · UDI-DI 04987669101353
Description
The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the examination data of the SPECULAR MICROSCOPE CEM-530 or use the data for follow-up within IMAGE FILING SOFTWARE NAVIS-EX. This function is added to the computer as a plug-in for NAVIS-EX. The examination data is displayed, analyzed, and used for follow-up. CEM Viewer can be used to display examination data on the Viewer screen or follow up data on the Follow-Up screen. The examination data is saved and managed within NAVIS-EX. The CEM Viewer data is imported to NAVIS-EX using separate software, Data Acquisition Service for NAVIS-EX.
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 structure/function |
| 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 use a specific prio |
| 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 records and images to be |
| 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 same time, their is a |
| 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 primary patient's thu |
| 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 index. If the user att |
| 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. | The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. |
| 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 the image permanentl |
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