System, Imaging, Optical Coherence Tomography (Oct)
Regulation 892.1560
3510(k)s in 12 months (46 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in NQQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ninepoint Medical, Inc. | 8 | 1 |
| Lightlab Imaging, Inc. | 8 | 0 |
| Spectrawave, Inc. | 5 | 0 |
| ABBOTT MEDICAL | 3 | 0 |
| Perimeter Medical Imaging, Inc. | 3 | 0 |
| Damae Medical | 2 | 0 |
| Gentuity, LLC | 2 | 0 |
| Imalux Corporation | 1 | 1 |
| Michelson Diagnostics, Ltd. | 2 | 0 |
| Agfa Healthcare N.V. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2018 | Ninepoint Medical Inc. NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188 Terminated |
NQQ | K143678 |
| Feb 1, 2012 | Imalux Corporation Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation, Cleveland, OH
The Niris Imaging System probe is used with the Niris Imaging System. The Niris Imag Terminated |
NQQ | K042894 |
| Feb 1, 2011 | Optovue Inc. Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA
Computer controlled opthalmic imaging system. Device scans the pat Terminated |
NQQ | K091404 |
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