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 | K171560 |
| 510k Number | K171560 |
| Device Name: | OTIS Optical Coherence Tomography System |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | Perimeter Medical Imaging, Inc. 47 Colborne Street Suite 202 Toronto, CA M5e 1p8 |
| Contact | Elizabeth Munro |
| Correspondent | Elizabeth Munro Perimeter Medical Imaging, Inc. 47 Colborne Street Suite 202 Toronto, CA M5e 1p8 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-30 |
| Decision Date | 2017-08-25 |
| Summary: | summary |