| Device |
digital breast tomosynthesis |
| Definition |
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer. |
| Product Code | OTE |
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
0
|
0
|
0
|
0
|
1
|
0
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0
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