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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, x-ray, film marking, radiographic
Regulation Description Radiographic film marking system.
Product CodeJAC
Regulation Number 892.1640
Device Class 1


Premarket Reviews
ManufacturerDecision
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 6
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUJI
  SUBSTANTIALLY EQUIVALENT 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Beekley Corporation II Jul-31-2012
2 GE Healthcare, LLC II Feb-27-2013
3 GE Healthcare, LLC II Feb-26-2013

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