Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device table, radiographic, tilting
Regulation Description Radiologic table.
Product CodeIXR
Regulation Number 892.1980
Device Class 2


Premarket Reviews
ManufacturerDecision
BIODEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 8
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
OEC-DIASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 2
TRI W-G, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Table break 1
Dislodged or dislocated 1
Material Protrusion 1
Torn material 1
Total Device Problems 4

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 2 0 2 2 2 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Sep-19-2008
2 Medical Positioning Inc II Apr-13-2011
3 Philips Healthcare Inc. II Aug-15-2012
4 Philips Healthcare Inc. II Jun-18-2012
5 Philips Medical Systems North America Co. Phillips II Sep-13-2010
6 Philips Medical Systems North America Co. Phillips II Mar-23-2010
7 Philips Medical Systems North America Co. Phillips II Sep-25-2007
8 Stille AB II Oct-20-2008
9 Stille-Sonesta, Inc II Feb-15-2007
10 Toshiba American Medical Systems Inc II Mar-16-2011

-
-