The following data is part of a premarket notification filed by Barco Nv with the FDA for Coronis Fusion 4mp Led.
| Device ID | K143157 |
| 510k Number | K143157 |
| Device Name: | Coronis Fusion 4MP LED |
| Classification | Display, Diagnostic Radiology |
| Applicant | BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk, BE |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk, BE |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2014-11-12 |
| Summary: | summary |