Panels › Ophthalmic › Product code NQE · Class 2
Microscope, Specular
Regulation 886.1850
0510(k)s in 12 months (9 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in NQE
| Company | 510(k)s | Recalls |
|---|---|---|
| Nidek Co., Ltd. | 3 | 2 |
| Konan Medical, Inc. | 4 | 0 |
| Tomey Corporation | 1 | 0 |
| Topcon Corporation | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2019 | Nidek, Inc. NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Informati Terminated |
NQE | K130565 K151706 +1 |
| Sep 1, 2016 | Nidek Inc SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09.
Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observatio Terminated |
NQE | K151706 |
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