AXIS Image Management System
SONOMED, INC. · Model Ver 5 · UDI-DI 00896100002002
Description
Software application for ophthalmic image management system with a browser-based interface for image review and analysis of ophthalmic images. Software utilizing available data from ophthalmic devices to provide views and tools that are clinically useful in helping to diagnose and monitor. A picture archiving and communication system to allow storage, retrieval, analysis, and management of digital images of the eye. Provides integration of different ophthalmic devices for any imaging modality. Complaint with DICOM interoperability standard and can integrate any DICOM-compliant device, including using DICOM modality worklists. Axis can integrate non-DICOM devices to provide data and imaging regardless of device type. Can be integrated with any EHR system via HL7 interface or other means. Functionality and access to images can be from AXIS server or AXIS cloud.
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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