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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device digital breast tomosynthesis
Definition To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Product CodeOTE
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 1 0 1 1 1 2

Device Problems
Structural problem 2
No Known Device Problem 1
Device handling issue 1
Total Device Problems 4

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Medical Solutions USA, Inc II Feb-25-2016

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