The following data is part of a premarket notification filed by Barcoview with the FDA for Coronis 2mp-21 And Mfgd 2621.
| Device ID | K052403 |
| 510k Number | K052403 |
| Device Name: | CORONIS 2MP-21 AND MFGD 2621 |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCOVIEW 35 PRESIDENT KENNEDYPARK Kortrijk, BE B-8500 |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel BARCOVIEW 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 | 2005-09-01 |
| Decision Date | 2005-09-15 |
| Summary: | summary |