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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device full field digital,system,x-ray,mammographic
Regulation Description Full-field digital mammography system.
Product CodeMUE
Regulation Number 892.1715
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJI
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
6 5 8 10 0 0 0 0 0 0

Device Problems
No Known Device Problem 2
Positioning Issue 1
Unintended movement 1
Incorrect display 1
Image display error 1
Poor quality image 1
Structural problem 1
Total Device Problems 8

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 1 0 3 2 3 5 1 0
Class III 0 1 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beekley Corporation III Jun-13-2014
2 Fujifilm Medical System USA, Inc. II May-21-2014
3 Fujifilm Medical Systems U.S.A., Inc. II May-06-2015
4 GE Healthcare, LLC II Jun-26-2013
5 GE Healthcare, LLC II Feb-20-2012
6 GE Healthcare, LLC II Oct-26-2011
7 GE Healthcare, LLC II Mar-18-2011
8 GE Healthcare, LLC II Mar-17-2011
9 Hologic, Inc. II Jun-03-2014
10 Hologic, Inc. II Sep-30-2013
11 Lorad, A Hologic, Inc. III May-28-2008
12 Siemens Medical Solutions USA, Inc II Dec-06-2014
13 Siemens Medical Solutions USA, Inc II Oct-17-2014
14 Siemens Medical Solutions USA, Inc II May-20-2014
15 Siemens Medical Solutions USA, Inc II Jul-11-2013
16 Siemens Medical Solutions USA, Inc II Jan-11-2012
17 Siemens Medical Solutions USA, Inc II May-07-2009

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