The following data is part of a premarket notification filed by Lightlab Imaging,inc. with the FDA for C7 Xr Imaging System.
| Device ID | K111201 |
| 510k Number | K111201 |
| Device Name: | C7 XR IMAGING SYSTEM |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | LIGHTLAB IMAGING,INC. ONE TECHNOLOGY PARK DRIVE Westford, MA 01886 |
| Contact | Bryan Cowell |
| Correspondent | Bryan Cowell LIGHTLAB IMAGING,INC. ONE TECHNOLOGY PARK DRIVE Westford, MA 01886 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-29 |
| Decision Date | 2011-08-10 |
| Summary: | summary |