The following data is part of a premarket notification filed by Barco Nv Barcoview with the FDA for Coronis 5mp Medical Flat Panel Display System.
| Device ID | K042221 |
| 510k Number | K042221 |
| Device Name: | CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO NV BARCOVIEW 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson BARCO NV BARCOVIEW 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-17 |
| Decision Date | 2004-12-30 |
| Summary: | summary |