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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device system, x-ray, mammographic
Regulation Description Mammographic x-ray system.
Product CodeIZH
Regulation Number 892.1710
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 8
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 9
IZI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LIV INTERNATIONAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
Minxray Inc
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
Remington Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Use of Device Issue 1
Improper or incorrect procedure or method 1
Other (for use when an appropriate device code cannot be identified) 1
Deployment 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 1 1 0 0 0 0 0 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beekley Corporation II Jun-26-2015
2 GE Healthcare II Sep-26-2008
3 General Electric Med Systems LLC II Jun-28-2007
4 Hologic, Inc. II Jun-03-2014

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