The following data is part of a premarket notification filed by Perimeter Medical Imaging, Inc. with the FDA for Perimeter Otis™ 1.0 Optical Coherence Tomography System.
| Device ID | K160240 |
| 510k Number | K160240 |
| Device Name: | Perimeter Otis™ 1.0 Optical Coherence Tomography System |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | PERIMETER MEDICAL IMAGING, INC. 156 FRONT STREET WEST, SUITE 501 Toronto, CA M5j 2l6 |
| Contact | Elizabeth Munro |
| Correspondent | Elizabeth Munro PERIMETER MEDICAL IMAGING, INC. 156 FRONT STREET WEST, SUITE 501 Toronto, CA M5j 2l6 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-05-13 |
| Summary: | summary |