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Huvitz Integrated Image Server HIIS-1
Huvitz Co., Ltd. · Model HIIS-1 · UDI-DI 08800019600794
10
510(k) clearances
47
Adverse events
14
Recalls
31
Facilities
Description
This software (HIIS-1) is a web-based software that can store, analyze, print and transmit the medical images and refraction data of patients acquired from ophthalmic devices on the computer where the software is installed.
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. | 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 |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.