510(k) K150237 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
ILUMIEN, Drageonfly OPTIS Imaging Catheter
| Applicant | Lightlab Imaging, Inc., Westford MA, US |
| Decision | Substantially Equivalent, May 5, 2015 |
| Received | Feb 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150237
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.