OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is an AI-enabled medical device from Perimeter Medical Imaging AI, Inc., listed by FDA (510(k), K203578) with a decision date of 2021-02-25. Review panel: Radiology.
| FDA submission number | K203578 |
|---|---|
| Pathway | 510(k) |
| Company | Perimeter Medical Imaging AI, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-02-25 |
| Decision | Substantially Equivalent |
| Product code | NQQ |
| Classification | System, Imaging, Optical Coherence Tomography (Oct) |
| Device class | 2 |
| Regulation number | 892.1560 |
| Review time (calendar days) | 80 |
| Applicant country | CA |
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.