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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device block, beam-shaping, radiation therapy
Regulation Description Radiation therapy beam-shaping block.
Product CodeIXI
Regulation Number 892.5710
Device Class 2


Premarket Reviews
ManufacturerDecision
COMPUTERIZED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
Elekta Instrument AB
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC
  SUBSTANTIALLY EQUIVALENT 2
NOMOS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
RADIATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 5
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material fragmentation 7
Total Device Problems 7

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 0 0 0 0 0
Class II 0 1 0 0 0 1 2 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Elekta, Inc. II Feb-25-2014
2 Elekta, Inc. II Sep-04-2013
3 Elekta, Inc. II Feb-26-2013
4 Philips Medical Systems North America Co. Phillips II Sep-01-2008
5 Siemens Medical Solutions USA, Inc II Mar-07-2012
6 Xoft Inc. I Apr-01-2011

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