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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device processor, radiographic-film, automatic
Product CodeIXW
Regulation Number 892.1900
Device Class 2


Premarket Reviews
ManufacturerDecision
PROTEC GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
VELOPEX INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 2 2
2015 2 2
2016 1 1
2017 1 1
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 2 2
Use of Device Problem 2 2
Electrical Shorting 1 1
Device Handling Problem 1 1
Thermal Decomposition of Device 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Display Difficult to Read 1 1
Fire 1 1
Failure to Power Up 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Information 3 3
Shock 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fujifilm Medical Systems U.S.A., Inc. II May-03-2016
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