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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, therapeutic, x-ray
Regulation Description X-ray radiation therapy system.
Product CodeJAD
Regulation Number 892.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
Action Products Incorporated
  SUBSTANTIALLY EQUIVALENT 1
ADAC
  SUBSTANTIALLY EQUIVALENT 2
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 4
COMPUTERIZED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 0 1 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Action Products Incorporated II Sep-22-2009
2 Carl Zeiss Meditec, Inc. II Nov-20-2012
3 Carl Zeiss Meditec, Inc. II Aug-10-2011

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