The following data is part of a premarket notification filed by Barco Nv with the FDA for Coronis Fusion 6mp - Mdcc-6530, Coronis Fusion 4mp - Mdcc-4430, Intuitive Workflow Tools (iwt).
| Device ID | K191845 |
| 510k Number | K191845 |
| Device Name: | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) |
| Classification | Display, Diagnostic Radiology |
| Applicant | Barco NV President Kennedypark 35 Kortrijk, BE 8500 |
| Contact | Julie Vandecandelaere |
| Correspondent | Julie Vandecandelaere Barco NV 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 | 2019-07-10 |
| Decision Date | 2019-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334002340 | K191845 | 000 |
| 05415334034754 | K191845 | 000 |
| 05415334034778 | K191845 | 000 |
| 05415334034792 | K191845 | 000 |
| 05415334034914 | K191845 | 000 |
| 05415334002050 | K191845 | 000 |
| 05415334025974 | K191845 | 000 |
| 05415334025981 | K191845 | 000 |
| 05415334028845 | K191845 | 000 |
| 05415334002326 | K191845 | 000 |
| 05415334034785 | K191845 | 000 |