Company ยท US
Lightlab Imaging, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2016. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 29, 2016 | K160878 | OPTIS Metallic Stent Optimization E.4 SW Lightlab Imaging, Inc. | NQQ |
| Oct 29, 2015 | K152120 | OPTIS Mobile System Lightlab Imaging, Inc. | NQQ |
| Aug 5, 2015 | K151286 | OPTIS Integrated System Mobile Workstation Lightlab Imaging, Inc. | NQQ |
| Jul 15, 2015 | K150878 | ILUMIEN OPTIS Lightlab Imaging, Inc. | NQQ |
| May 5, 2015 | K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter Lightlab Imaging, Inc. | NQQ |
| Sep 19, 2014 | K141453 | ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER Lightlab Imaging, Inc. | DQO |
| Aug 18, 2014 | K141769 | OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER Lightlab Imaging, Inc. | DQO |
| Jan 30, 2013 | K123369 | ILUMIEN OPTIS Lightlab Imaging, Inc. | NQQ |
| Aug 10, 2011 | K111201 | C7 XR IMAGING SYSTEM Lightlab Imaging, Inc. | NQQ |
| Apr 30, 2010 | K093857 | C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES Lightlab Imaging, Inc. | NQQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||