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TPLC
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Device
system, x-ray, mammographic
Regulation Description
Mammographic x-ray system.
Product Code
IZH
Regulation Number
892.1710
Device Class
2
Premarket Reviews
Manufacturer
Decision
HOLOGIC, INC
SUBSTANTIALLY EQUIVALENT
1
IMS GIOTTO S.P.A.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
7
7
2021
9
9
2022
4
4
2023
8
8
2024
5
5
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended System Motion
6
6
Adverse Event Without Identified Device or Use Problem
5
5
Imprecision
4
4
Use of Device Problem
3
3
Device Operational Issue
2
2
Poor Quality Image
2
2
Defective Device
2
2
Unexpected Shutdown
1
1
Malposition of Device
1
1
Communication or Transmission Problem
1
1
Application Program Problem
1
1
Device Fell
1
1
Failure to Obtain Sample
1
1
Flare or Flash
1
1
Mechanics Altered
1
1
Calibration Problem
1
1
Optical Problem
1
1
Product Quality Problem
1
1
Detachment of Device or Device Component
1
1
Electrical Shorting
1
1
Activation Failure
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
13
13
No Consequences Or Impact To Patient
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Insufficient Information
3
3
Skin Tears
3
3
Pain
2
2
Unspecified Infection
1
1
Radiation Exposure, Unintended
1
1
Hematoma
1
1
Perforation
1
1
Laceration(s)
1
1
Scar Tissue
1
1
Physical Entrapment
1
1
Muscle/Tendon Damage
1
1
Unspecified Tissue Injury
1
1
Hemorrhage/Bleeding
1
1
Deformity/ Disfigurement
1
1
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