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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device system,x-ray,extraoral source,digital
Regulation Description Extraoral source x-ray system.
Product CodeMUH
Regulation Number 872.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
AGFA COMPANY
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
GENDEX
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 3
PROGENY, INC.
  SUBSTANTIALLY EQUIVALENT 2
SOMETECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SOPRO
  SUBSTANTIALLY EQUIVALENT 1
TROPHY
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Detachment of device component 1
Computer software issue 1
Fire 1
Instruction for use issue 1
No Known Device Problem 1
Patient Data Issue 1
Total Device Problems 6

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 1 2 0 0 0 0 1 2 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Carestream Health, Inc. II Apr-03-2015
2 Gendex Dental Systems II Jul-17-2009
3 Imaging Sciences International, LLC II May-22-2009
4 Imaging Sciences Intl Inc II Sep-01-2008
5 Midmark Corp dba Progeny Inc II Jan-25-2016
6 Midmark Corp dba Progeny Inc II Jan-09-2014
7 Villa Radiology Systems LLC II Nov-06-2015

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