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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device couch, radiation therapy, powered
Regulation Description Powered radiation therapy patient support assembly.
Product CodeJAI
Regulation Number 892.5770
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 2
MDS NORDION
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC
  SUBSTANTIALLY EQUIVALENT 2
NOMOS
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2

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 3 0 2 2 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Inc II Jan-11-2011
2 Accuray Inc II Jan-14-2009
3 Accuray Incorporated II Apr-20-2013
4 Elekta, Inc. II Mar-19-2015
5 Elekta, Inc. II Apr-25-2014
6 Elekta, Inc. II Apr-09-2013
7 Elekta, Inc. II Feb-03-2011
8 Elekta, Inc. II Apr-23-2010
9 Siemens Medical Solutions USA, Inc II Jan-17-2014
10 Siemens Medical Solutions USA, Inc II Apr-19-2011
11 Siemens Medical Solutions USA, Inc II Oct-28-2010

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