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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device collimator, manual, radiographic
Product CodeIZX
Regulation Number 892.1610
Device Class 2


Premarket Reviews
ManufacturerDecision
RALCO S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Shimadzu Medical Systems II Nov-08-2012
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