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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 processor, radiographic-film, automatic
Regulation Description Automatic radiographic film processor.
Product CodeIXW
Regulation Number 892.1900
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 5
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 31
FUJI
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 2
Device handling issue 1
Burn of device or device component 1
Display misread 1
Total Device Problems 5

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 Fujifilm Medical Systems U.S.A., Inc. II May-03-2016

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