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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
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
 

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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
Detachment of device component 4
Device inoperable 3
Component falling 2
Device displays error message 2
Device operates differently than expected 1
Difficult to open or close 1
Dislodged or dislocated 1
Material Protrusion 1
No Known Device Problem 1
Positioning Issue 1
Torn material 1
Unintended movement 1
Application interface becomes non-functional or program exits abnormally 1
Mechanical issue 1
Table break 1
High test results 1
Circuit Failure 1
Total Device Problems 24

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 2 2 0 2 2 2 0 0 0 1
Class III 0 0 0 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 Shimadzu Medical Systems II Apr-28-2016
9 Stille AB II Oct-20-2008
10 Stille-Sonesta, Inc II Feb-15-2007
11 Toshiba American Medical Systems Inc II Mar-16-2011

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