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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tomographic imager combining emission computed tomography with nuclear magnetic resonance
Regulation Description Emission computed tomography system.
Definition Imager that generates both both magnetic resonance (mr) and positron emission tomography (pet) images and provides registration and fusion of these images. Pet and mr images can be acquired either simultaneously or sequentially. Anatomical mr images are used for pet attenuation correction.
Product CodeOUO
Regulation Number 892.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Image display error 1
No Information 1
Improper or incorrect procedure or method 1
Delamination 1
Total Device Problems 4

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 1 0 0 3 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Nov-10-2015
2 Philips Medical Systems (Cleveland) Inc II Aug-31-2015
3 Philips Medical Systems (Cleveland) Inc II Jun-11-2015
4 Philips Medical Systems (Cleveland) Inc II May-22-2012

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