The following data is part of a premarket notification filed by Perimeter Medical Imaging Ai, Inc. with the FDA for Otis 2.1 Optical Coherence Tomography System, Thia Optical Coherence Tomography System.
| Device ID | K203578 |
| 510k Number | K203578 |
| Device Name: | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | Perimeter Medical Imaging AI, Inc. 359 Eastern Avenue, Suite 110 Toronto, CA M4m 1b7 |
| Contact | Elizabeth Munro |
| Correspondent | Cindy Domecus Domecus Consulting Services, LLC 1171 Barroihet Avenue, Hillsborough, CA 94010 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-07 |
| Decision Date | 2021-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20754016215029 | K203578 | 000 |
| 00754016215018 | K203578 | 000 |
| 00754016215049 | K203578 | 000 |