510(k) K153283 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
VivoSight Dx Topical OCT System
| Applicant | Michelson Diagnostics, Ltd., Maidstone, GB |
| Decision | Substantially Equivalent, Aug 11, 2016 |
| Received | Nov 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153283
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.