510(k) K192922 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
| Applicant | Gentuity, LLC, Sudbury MA, US |
| Decision | Substantially Equivalent, Feb 20, 2020 |
| Received | Oct 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192922
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.