510(k) K250684 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
OPUSWAVE Dual Sensor Imaging System
| Applicant | Terumo Cardiovascular Systems Thi Plant, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jul 2, 2025 |
| Received | Mar 6, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250684
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.