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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device coil, magnetic resonance, specialty
Regulation Description Magnetic resonance diagnostic device.
Product CodeMOS
Regulation Number 892.1000
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ESAOTE
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 21
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 18
INSIGHTEC
  SUBSTANTIALLY EQUIVALENT 3
INVIVO
  SUBSTANTIALLY EQUIVALENT 18
MAYO CLINIC
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 18
MONTERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MRI DEVICES CORP.
  SUBSTANTIALLY EQUIVALENT 65
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 9
SIEMENS
  SUBSTANTIALLY EQUIVALENT 13
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 2
USA INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 63
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Positioning Issue 1
No Information 1
Device operates differently than expected 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 2 0 2 0 0 2 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II May-04-2012
2 GE Medical Systems, LLC II Dec-28-2015
3 Hitachi Medical Systems America Inc II Aug-10-2015
4 Hitachi Medical Systems America Inc II May-19-2010
5 NeoCoil, LLC II Feb-29-2016
6 Philips Medical Systems North America Co. Phillips II Sep-22-2010
7 Quality Electrodynamics LLC II Sep-06-2012
8 Quality Electrodynamics Llc II Sep-10-2009

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