510(k) K042894 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
IMALUX NIRIS IMAGING SYSTEM
| Applicant | Imalux Corporation, Cleveland OH, US |
| Decision | Substantially Equivalent, Nov 19, 2004 |
| Received | Oct 20, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042894
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.