Panels › Ophthalmic › Product code HKI · Class 2
Camera, Ophthalmic, Ac-Powered
Regulation 886.1120
3510(k)s in 12 months (157 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in HKI
| Company | 510(k)s | Recalls |
|---|---|---|
| Canon USA, Inc. | 19 | 0 |
| Kowa Co. , Ltd. | 14 | 0 |
| Clarity Medical Systems | 4 | 3 |
| Nidek Co., Ltd. | 5 | 2 |
| Topcon Corp. | 7 | 0 |
| Optomed OY | 5 | 0 |
| Nidek Technologies Srl | 4 | 0 |
| Tearscience, Inc. | 4 | 0 |
| Kowa Optimed, Inc. | 3 | 0 |
| Medivision Medical Imaging, Ltd. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2019 | Merge Healthcare, Inc. The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System
Product Usage:
The WinStation Retinal Imager has the same intended use as other fundus camera Terminated |
HKI | K982689 |
| Jul 27, 2017 | Optovue, Inc. iFusion, Device Listing Number D203271.
Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the r Terminated |
HKI | K130656 |
| Dec 9, 2016 | Merge Healthcare, Inc. Merge Eye Station
f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior Terminated |
HKI | K913929 |
| Dec 9, 2016 | Merge Healthcare, Inc. Merge Eye Station.
f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS).
Model number 136 T1700 Capture Stat Terminated |
HKI | K913929 |
| Jul 2, 2014 | Nidek Inc Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye.
Distributed by Nidek, Inc, and Marco Opthalmic Inc. Terminated |
HKI | K113451 |
| Mar 20, 2014 | Clarity Medical Systems Inc Halogen Lamp component in RetCam 3 System -
Clarity Medical Systems, Inc;
Pleasanton, CA.
General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatr Terminated |
HKI | K081858 |
| Mar 7, 2014 | Clarity Medical Systems Inc RetCam 3, RetCam Portable and RetCam Shuttle;
manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588.
General ophthalmic imaging including retinal, corneal and external imaging. Terminated |
HKI | K081858 K090326 +1 |
| Aug 23, 2013 | Nidek Inc NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images. Terminated |
HKI | K113451 |
| Feb 24, 2012 | Clarity Medical Systems Inc Retcam3 & Retcam Shuttle with version 6.0 software.
Clarity Medical Systems, Inc.
5775 W. Las Positas Blvd, Suite 200
Pleasanton, CA 94588
General ophthalmic imaging including retinal, corneal and e Terminated |
HKI | K081858 K090326 +1 |
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