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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device display, diagnostic radiology
Regulation Description Picture archiving and communications system.
Definition The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
Product CodePGY
Regulation Number 892.2050
Device Class 2

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 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Eizo Corporation II Jul-16-2015

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