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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, simulation, radiation therapy
Regulation Description Radiation therapy simulation system.
Product CodeKPQ
Regulation Number 892.5840
Device Class 2


Premarket Reviews
ManufacturerDecision
ADAC
  SUBSTANTIALLY EQUIVALENT 1
COMPUTERIZED MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
IMPAC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 4
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 1
VARIAN
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Use of Device Issue 1
Total Device Problems 1

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

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Jan-30-2013
2 GE Medical Systems, LLC II Aug-17-2009
3 Siemens Medical Solutions USA, Inc II Jan-17-2014
4 Siemens Medical Solutions USA, Inc II Jan-13-2009
5 Siemens Medical Solutions USA, Inc II Jun-28-2008
6 Siemens Medical Solutions USA, Inc II Jan-31-2008
7 Siemens Medical Solutions USA, Inc II Nov-20-2014
8 Varian Medical Systems Inc II Nov-08-2007
9 Varian Medical Systems Oncology Systems II Jul-30-2008

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