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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device collimator, manual, radiographic
Regulation Description Diagnostic x-ray beam-limiting device.
Product CodeIZX
Regulation Number 892.1610
Device Class 2


Premarket Reviews
ManufacturerDecision
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 3
WU'S
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Disassembly 1
Total Device Problems 1

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 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Shimadzu Medical Systems II Nov-08-2012
2 Summit Industries Inc. II Aug-29-2007

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