510(k) K160878 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
OPTIS Metallic Stent Optimization E.4 SW
| Applicant | Lightlab Imaging, Inc., Westford MA, US |
| Decision | Substantially Equivalent, Jun 29, 2016 |
| Received | Mar 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160878
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.