The following data is part of a premarket notification filed by Barco N.v. with the FDA for Coronis Uniti.
| Device ID | K151505 |
| 510k Number | K151505 |
| Device Name: | Coronis Uniti |
| Classification | Display, Diagnostic Radiology |
| Applicant | Barco N.V. President Kennedypark 35 Kortrijk, BE 8500 |
| Contact | Franky Dubois |
| Correspondent | Franky Dubois Barco N.V. President Kennedypark 35 Kortrijk, BE 8500 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-04 |
| Decision Date | 2015-07-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CORONIS UNITI 79161827 4938882 Live/Registered |
BARCO N.V. 2015-01-19 |