The following data is part of a premarket notification filed by Barco Nv with the FDA for Nio 2mp (mdng-2121).
| Device ID | K091172 |
| 510k Number | K091172 |
| Device Name: | NIO 2MP (MDNG-2121) |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO NV 35 PRESIDENT KENNEDYPARK 8500 Kortrijk, BE |
| Contact | Lieven De Wandel |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-22 |
| Decision Date | 2009-05-05 |