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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube mount, x-ray, diagnostic
Regulation Description Diagnostic x-ray tube mount.
Product CodeIYB
Regulation Number 892.1770
Device Class 1


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 5
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
WU'S
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Detachment of device component 2
Component(s), broken 1
Total Device Problems 3

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

Recalls
Manufacturer Recall Class Date Posted
1 Del Medical Systems Group II Jun-30-2009
2 Summit Industries Inc. II Dec-01-2014

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