The following data is part of a premarket notification filed by Barco Nv with the FDA for Barco Mammo Tomosynthesis.
| Device ID | K103792 |
| 510k Number | K103792 |
| Device Name: | BARCO MAMMO TOMOSYNTHESIS |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO NV 35 PRESIDENT KENNEDYPARK 8500 Kortrijk, BE |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel BARCO NV 35 PRESIDENT KENNEDYPARK 8500 Kortrijk, BE |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-27 |
| Decision Date | 2011-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334001572 | K103792 | 000 |
| 05415334001565 | K103792 | 000 |
| 05415334001534 | K103792 | 000 |
| 05415334001527 | K103792 | 000 |