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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, x-ray, mammographic
Product CodeIZH
Regulation Number 892.1710
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC
  SUBSTANTIALLY EQUIVALENT 1
IMS GIOTTO S.P.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 24 24
2019 39 39
2020 7 7
2021 9 9
2022 4 4
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 37 37
Imprecision 12 12
Device Operational Issue 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Unintended Movement 3 3
Device Fell 2 2
Poor Quality Image 2 2
Device Contamination with Body Fluid 2 2
Defective Device 2 2
Malposition of Device 2 2
Calibration Problem 2 2
Break 2 2
Circuit Failure 2 2
Positioning Failure 2 2
Erratic or Intermittent Display 1 1
Increase in Pressure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Separation 1 1
Improper or Incorrect Procedure or Method 1 1
Communication or Transmission Problem 1 1
Detachment of Device or Device Component 1 1
Application Program Problem 1 1
Failure to Obtain Sample 1 1
Loose or Intermittent Connection 1 1
Moisture Damage 1 1
Unexpected Shutdown 1 1
Activation Failure 1 1
Optical Problem 1 1
Output Problem 1 1
Positioning Problem 1 1
Power Problem 1 1
Electrical Shorting 1 1
Flare or Flash 1 1
Installation-Related Problem 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 44 44
No Clinical Signs, Symptoms or Conditions 12 12
Not Applicable 9 9
No Known Impact Or Consequence To Patient 6 6
Radiation Exposure, Unintended 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Insufficient Information 2 2
Skin Tears 2 2
Bruise/Contusion 2 2
Pain 2 2
Perforation 2 2
Scar Tissue 1 1
Tissue Damage 1 1
Fainting 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
No Patient Involvement 1 1
Deformity/ Disfigurement 1 1
Skin Inflammation 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1

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