The following data is part of a premarket notification filed by Imalux Corporation with the FDA for Imalux Niris Imaging System.
| Device ID | K042894 |
| 510k Number | K042894 |
| Device Name: | IMALUX NIRIS IMAGING SYSTEM |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | IMALUX CORPORATION 1771 EAST 30TH STREET Cleveland, OH 44114 |
| Contact | Stephanie Harrington |
| Correspondent | Stephanie Harrington IMALUX CORPORATION 1771 EAST 30TH STREET Cleveland, OH 44114 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-20 |
| Decision Date | 2004-11-19 |
| Summary: | summary |