510(k) K203578 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
| Applicant | Perimeter Medical Imaging Ai, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Feb 25, 2021 |
| Received | Dec 7, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203578
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.