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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, radiation therapy, charged-particle, medical
Regulation Description Medical charged-particle radiation therapy system.
Product CodeLHN
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 3
COMPUTERIZED MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
INTRAOP MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MASSACHUSETTS GENERAL HOSPITAL
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
VARIAN
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Detachment of device component 2
Computer software issue 1
Unexpected therapeutic results 1
Device operates differently than expected 1
Total Device Problems 5

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 1 0 0 0 0 0 5 2 2
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hitachi America, Ltd., Power Systems Division II Jul-18-2015
2 Hitachi Medical Systems America Inc III Jul-24-2008
3 Intraop Medical Corporation II Oct-03-2008
4 Ion Beam Applications S.A. II Dec-19-2014
5 Ion Beam Applications S.A. II Apr-24-2014
6 Mevion Medical Systems, Inc. II Apr-20-2016
7 Mevion Medical Systems, Inc. II Feb-08-2016
8 Mevion Medical Systems, Inc. II Dec-12-2014
9 Mevion Medical Systems, Inc. II Mar-22-2014
10 Mizuho Orthopedic Systems Inc II Dec-13-2007
11 Philips Electronics North America Corporation II Jul-22-2015
12 VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH II Jun-21-2014

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