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Chongqing Kanghuaruiming S&T Co., Ltd.. · Model APS-BER · UDI-DI 06951214400084
Description
This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein-Angiography camera and digital-fundus-images acquisition and processing system, which can continuously display real-time, high quality color fundus images as well as black-white Fundus-Fluorescein-Angiography video images. The fundus images acquisition and processing system can process (full digital), record (real-time and completely) and save the color fundus images as well as retinal-fluorescein-angiography dynamic & static images into the computer. You can modify pictures, check reports, edit Graph-texts and manage all the dates at any time you want; you can measure and calculate the size of the case focus; you can zoom, move, stick, and put together the pictures; you can adjust the color on the picture, you can also record all the data on the CD, which can assistant scientific research and teaching. This system has combine function of many fundus image acquisition instruments, which can support medical treatments.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-12-20 | Merge Healthcare, Inc. | Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allo |
| 2017-07-27 | Optovue, Inc. | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| 2016-12-09 | Merge Healthcare, Inc. | This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user. |
| 2016-12-09 | Merge Healthcare, Inc. | Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to |
| 2014-06-16 | Nidek Inc | Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. |
| 2014-03-07 | Clarity Medical Systems Inc | One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the |
| 2014-01-24 | Clarity Medical Systems Inc | Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly. |
| 2013-08-01 | Nidek Inc | Under certain circumstances, the Left eye image may be saved as the Right eye image. |
| 2012-02-02 | Clarity Medical Systems Inc | Still images extracted from video recordings may be mislabeled as to right and left eye. |
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