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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device camera, scintillation (gamma)
Regulation Description Scintillation (gamma) camera.
Product CodeIYX
Regulation Number 892.1100
Device Class 1


Premarket Reviews
ManufacturerDecision
ADAC
  SUBSTANTIALLY EQUIVALENT 6
DANISH DIAGNOSTIC
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 18
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 6
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Use of Device Issue 4
No Known Device Problem 2
Device handling issue 1
Component(s), overheating of 1
Mechanical issue 1
Total Device Problems 9

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 0
Class III 0 0 0 0 0 0 0 0 0 0


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