The following data is part of a premarket notification filed by Barco Nv with the FDA for Coronis Fusion 10mp, Model Mdcg-10130.
| Device ID | K093197 |
| 510k Number | K093197 |
| Device Name: | CORONIS FUSION 10MP, MODEL MDCG-10130 |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk, BE B-8500 |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk, BE B-8500 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-09 |
| Decision Date | 2010-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334001497 | K093197 | 000 |