510(k) K093857 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
| Applicant | Lightlab Imaging, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Apr 30, 2010 |
| Received | Dec 16, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093857
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.