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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device x-ray, tomography, computed, dental
Regulation Description Computed tomography x-ray system.
Definition Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
Product CodeOAS
Regulation Number 892.1750
Device Class 2


Premarket Reviews
ManufacturerDecision
TROPHY
  SUBSTANTIALLY EQUIVALENT 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 Villa Radiology Systems LLC II Nov-06-2015

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