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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device interventional fluoroscopic x-ray system
Regulation Description Image-intensified fluoroscopic x-ray system.
Definition Interventional fluoroscopy
Product CodeOWB
Regulation Number 892.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
DORNIER MEDTECH
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 28
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS
  SUBSTANTIALLY EQUIVALENT 10
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 4
WU'S
  SUBSTANTIALLY EQUIVALENT 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 2
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II May-14-2013
2 GE Healthcare, LLC II Apr-18-2013

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