The following data is part of a premarket notification filed by Barco Nv with the FDA for Nio Color 2mp.
| Device ID | K111991 |
| 510k Number | K111991 |
| Device Name: | NIO COLOR 2MP |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk, BE 8500 |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk, BE 8500 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-13 |
| Decision Date | 2011-08-11 |