The following data is part of a premarket notification filed by Barco N.v. with the FDA for Mmpc-4127f1.
| Device ID | K172922 |
| 510k Number | K172922 |
| Device Name: | MMPC-4127F1 |
| Classification | Whole Slide Imaging System |
| Applicant | Barco N.V. President Kennedypark 35 Kortrijk, BE 8500 |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel Barco N.V. President Kennedypark 35 Kortrijk, BE 8500 |
| Product Code | PSY |
| CFR Regulation Number | 864.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2017-12-21 |
| Summary: | summary |