• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device screen, intensifying, radiographic
Regulation Description Radiographic intensifying screen.
Product CodeEAM
Regulation Number 892.1960
Device Class 1


Premarket Reviews
ManufacturerDecision
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 7
FUJI
  SUBSTANTIALLY EQUIVALENT 7
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

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 0 0
Class III 0 0 0 0 0 0 0 0 0 0


-
-