The following data is part of a premarket notification filed by Barco N.v. with the FDA for Coronis Fusion 6mp.
| Device ID | K130103 |
| 510k Number | K130103 |
| Device Name: | CORONIS FUSION 6MP |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO N.V. PRESIDENT KENNEDYPARK 35 Kortrijk, BE 8500 |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel BARCO N.V. PRESIDENT KENNEDYPARK 35 Kortrijk, BE 8500 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-15 |
| Decision Date | 2013-02-08 |