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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, image management, ophthalmic
Regulation Description Picture archiving and communications system.
Product CodeNFJ
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 3
DIGITAL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
KONAN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPTOS PLC
  SUBSTANTIALLY EQUIVALENT 1
TOPCON CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Image display error 6
Total Device Problems 6

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

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Inc II May-26-2010

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