The following data is part of a premarket notification filed by Barco Nv with the FDA for Nio Fusion 12mp (mdnc-12130).
| Device ID | K203106 |
| 510k Number | K203106 |
| Device Name: | Nio Fusion 12MP (MDNC-12130) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-15 |
| Decision Date | 2020-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334028425 | K203106 | 000 |
| 05415334044357 | K203106 | 000 |