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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, digital image communications, radiological
Regulation Description Medical image communications device.
Product CodeLMD
Regulation Number 892.2020
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ADAC
  SUBSTANTIALLY EQUIVALENT 1
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
APPLICARE MEDICAL IMAGING, B.V.
  SUBSTANTIALLY EQUIVALENT 1
CERNER CORP.
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 7
FUJI
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
IDX SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 4
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL NAVIGATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Computer software issue 2
Loss of Data 2
Device operates differently than expected 2
Defective component 1
Total Device Problems 7

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

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Corp. II Jul-01-2008
2 CompView Medical, LLC II Jan-13-2016
3 GE Healthcare Integrated IT Solutions II Jan-12-2009
4 Ge Healthcare It II Dec-05-2013
5 Karl Storz Endoscopy II Jul-10-2014
6 Siemens Medical Solutions USA, Inc II Jun-02-2015
7 Siemens Medical Solutions USA, Inc II Jun-05-2007
8 Stryker Endoscopy II Jan-07-2011

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