K103792 is an FDA 510(k) clearance for the BARCO MAMMO TOMOSYNTHESIS. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Barco N.V. (8500 Kortrijk, BE). The FDA issued a Cleared decision on March 4, 2011, 67 days after receiving the submission on December 27, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K103792 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2010 |
| Decision Date | March 04, 2011 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |