The following data is part of a premarket notification filed by Perimeter Medical Imaging, Inc. with the FDA for Otis Optical Coherence Tomography System.
| Device ID | K190404 |
| 510k Number | K190404 |
| Device Name: | OTIS Optical Coherence Tomography SYstem |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | Perimeter Medical Imaging, Inc. 1 Yonge Street, Suite 201 Toronto, CA M5e !e6 |
| Contact | Elizabeth Munro |
| Correspondent | Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive California, CA 94010 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-03-26 |