510(k) K243016 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
Starlight Imaging Catheter
| Applicant | Spectrawave, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Mar 20, 2025 |
| Received | Sep 27, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243016
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.