510(k) K242924 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
OPXION Optical Skin Viewer (OPXSV1-01F)
| Applicant | Opxion Technology, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Jun 23, 2025 |
| Received | Sep 24, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242924
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.