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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assembly, tube housing, x-ray, diagnostic
Regulation Description Diagnostic x-ray tube housing assembly.
Product CodeITY
Regulation Number 892.1760
Device Class 1


Premarket Reviews
ManufacturerDecision
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Artifact 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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