Panels › Ophthalmic › Product code HLI · Class 2
Ophthalmoscope, Ac-Powered
Regulation 886.1570
0510(k)s in 12 months (87 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in HLI
| Company | 510(k)s | Recalls |
|---|---|---|
| Optovue, Inc. | 7 | 4 |
| Carl Zeiss Meditec, Inc. | 7 | 1 |
| Keeler Instruments, Inc. | 6 | 1 |
| Neitz Instruments Company, Ltd. | 7 | 0 |
| Heidelberg Engineering | 5 | 0 |
| Talia Technology , Ltd. | 5 | 0 |
| Welch Allyn, Inc. | 5 | 0 |
| Woodlyn, Inc. | 5 | 0 |
| American Medical Optics | 3 | 0 |
| Bioptigen, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2021 | Haag-Streit USA Inc OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 Open, Classified |
HLI | K142953 |
| Jul 27, 2017 | Optovue, Inc. iVue 500 with iScan, D216606.
Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measureme Terminated |
HLI | K133892 |
| Jul 27, 2017 | Optovue, Inc. iVue with Normative Database, Device Listing Number D185549.
Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axi Terminated |
HLI | K121739 |
| Mar 16, 2016 | Optovue, Inc. iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US)
Opthalmic: iVue is a non-contact, high resolution tomographic imaging dev Terminated |
HLI | K121739 K133892 |
| May 31, 2013 | Optovue, Inc. Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.
Intended for in vivo imaging. Terminated |
HLI | K121739 |
| Sep 3, 2009 | Carl Zeiss Meditec Inc Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, pro Terminated |
HLI | K030433 K033123 |
| May 22, 2008 | Keeler Instruments Inc Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008 Terminated |
HLI | K854244 |
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