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TPLC
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Device
block, beam-shaping, radiation therapy
Product Code
IXI
Regulation Number
892.5710
Device Class
2
Premarket Reviews
Manufacturer
Decision
.DECIMAL, INC.
SUBSTANTIALLY EQUIVALENT
4
3D SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
CURA MEDICAL TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
2
ELEKTA LIMITED
SUBSTANTIALLY EQUIVALENT
1
ONCOLOGY TECH, LLC
SUBSTANTIALLY EQUIVALENT
1
VHA DEAN
SUBSTANTIALLY EQUIVALENT
1
XOFT, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2016
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1
1
Loose or Intermittent Connection
1
1
Mechanical Problem
1
1
Component Falling
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Elekta, Inc.
II
Feb-25-2014
2
Elekta, Inc.
II
Sep-04-2013
3
Elekta, Inc.
II
Feb-26-2013
4
Siemens Medical Solutions USA, Inc
II
Mar-07-2012
5
Xoft Inc.
I
Apr-01-2011
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