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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device system, x-ray, mammographic
Regulation Description Mammographic x-ray system.
Product CodeIZH
Regulation Number 892.1710
Device Class 2


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

MDR Year MDR Reports MDR Events
2016 9 9
2017 12 12
2018 24 24
2019 39 39
2020 7 7
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 36 36
Imprecision 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Device Operational Issue 5 5
Break 4 4
Device Operates Differently Than Expected 4 4
Failure to Align 3 3
Unintended Movement 3 3
Poor Quality Image 3 3
Malposition of Device 2 2
Circuit Failure 2 2
Improper or Incorrect Procedure or Method 2 2
Device Contamination with Body Fluid 2 2
Defective Device 2 2
Positioning Failure 2 2
Mechanical Problem 2 2
No Device Output 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Material Separation 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Application Program Problem 1 1
Calibration Problem 1 1
Communication or Transmission Problem 1 1
Detachment of Device or Device Component 1 1
Device Reprocessing Problem 1 1
Installation-Related Problem 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Output Problem 1 1
Insufficient Information 1 1
Failure to Advance 1 1
Increase in Pressure 1 1
Component Falling 1 1
Erratic or Intermittent Display 1 1
Loose or Intermittent Connection 1 1
Moisture Damage 1 1
Facilities Issue 1 1
Flare or Flash 1 1
Device Fell 1 1
Optical Problem 1 1
Positioning Problem 1 1
Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 47 47
No Known Impact Or Consequence To Patient 14 14
Not Applicable 12 12
No Clinical Signs, Symptoms or Conditions 5 5
Pain 4 4
Radiation Exposure, Unintended 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Skin Tears 2 2
Insufficient Information 2 2
Perforation 2 2
No Patient Involvement 2 2
No Information 2 2
Bruise/Contusion 2 2
Bone Fracture(s) 1 1
Unspecified Infection 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Tissue Damage 1 1
Burning Sensation 1 1
Discomfort 1 1
No Code Available 1 1
Rash 1 1
Swelling 1 1
Deformity/ Disfigurement 1 1
Skin Inflammation 1 1
Burn(s) 1 1
Erythema 1 1
Fainting 1 1
Hematoma 1 1

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