The following data is part of a premarket notification filed by Lightlab Imaging,inc. with the FDA for C7 Xr Imaging System With C7 Dragonfly Imaging Catheter And Disposable Accessories.
| Device ID | K093857 |
| 510k Number | K093857 |
| Device Name: | C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | LIGHTLAB IMAGING,INC. 7 TRAIL HOUSE CT Rockville, MD 20850 |
| Contact | Christine Brauer |
| Correspondent | Christine Brauer LIGHTLAB IMAGING,INC. 7 TRAIL HOUSE CT Rockville, MD 20850 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-16 |
| Decision Date | 2010-04-30 |
| Summary: | summary |