The following data is part of a premarket notification filed by Barco Nv with the FDA for Barco 5mp Mammo, Model Mdmg-5221.
| Device ID | K090603 |
| 510k Number | K090603 |
| Device Name: | BARCO 5MP MAMMO, MODEL MDMG-5221 |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO NV 15425 SW BEAVERTON CREEK COURT Beaverton, OR 97006 -5168 |
| Contact | Albert Xthona |
| Correspondent | Albert Xthona BARCO NV 15425 SW BEAVERTON CREEK COURT Beaverton, OR 97006 -5168 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-05 |
| Decision Date | 2009-04-22 |