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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device block, beam-shaping, radiation therapy
Product CodeIXI
Regulation Number 892.5710
Device Class 2


Premarket Reviews
ManufacturerDecision
.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
Component Falling 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Adverse Event Without Identified Device or Use Problem 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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