510(k) K242239 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
| Applicant | Gentuity, LLC, Sudbury MA, US |
| Decision | Substantially Equivalent, Aug 16, 2024 |
| Received | Jul 30, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242239
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.