The following data is part of a premarket notification filed by Barco N.v. with the FDA for Mammo Tomosynthesis (mdmg-5221).
| Device ID | K161229 |
| 510k Number | K161229 |
| Device Name: | Mammo Tomosynthesis (MDMG-5221) |
| Classification | Display, Diagnostic Radiology |
| 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 | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-02 |
| Decision Date | 2016-05-18 |
| Summary: | summary |