510(k) K252633 ยท OBO Tomography, Optical Coherence
UNITY DX (UDX)
| Applicant | Cylite Pty. , Ltd., Mulgrave, AU |
| Decision | Substantially Equivalent, Dec 23, 2025 |
| Received | Aug 20, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252633
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.