510(k) K253101 · NQQ System, Imaging, Optical Coherence Tomography (Oct)
HyperVue Imaging System - Integrated
| Applicant | Spectrawave, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Dec 15, 2025 |
| Received | Sep 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253101
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.