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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device full field digital, system, x-ray, mammographic
Regulation Description Full-field digital mammography system.
Product CodeMUE
Regulation Number 892.1715
Device Class 2


Premarket Reviews
ManufacturerDecision
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
IMS GIOTTO S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
METALTRONICA SPA
  SUBSTANTIALLY EQUIVALENT 1
PLANMED OY
  SUBSTANTIALLY EQUIVALENT 2
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VMI TECNOLOGIAS LTDA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 49 49
2021 25 25
2022 36 36
2023 29 29
2024 33 33
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 110 110
Break 13 13
Use of Device Problem 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Unintended Movement 5 5
Device Operational Issue 3 3
Insufficient Information 3 3
Fire 2 2
Mechanical Problem 2 2
Positioning Problem 2 2
Device Handling Problem 2 2
No Apparent Adverse Event 2 2
Mechanical Jam 2 2
Unintended Collision 2 2
Output Problem 1 1
Physical Resistance/Sticking 1 1
Device Alarm System 1 1
Crack 1 1
Unintended Electrical Shock 1 1
Material Disintegration 1 1
Material Erosion 1 1
Device Fell 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Data Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure to Power Up 1 1
Structural Problem 1 1
Data Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Detachment of Device or Device Component 1 1
Fracture 1 1
Melted 1 1
Display or Visual Feedback Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Displays Incorrect Message 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 113 113
No Consequences Or Impact To Patient 35 35
Insufficient Information 8 8
Laceration(s) 4 4
Bone Fracture(s) 3 3
No Known Impact Or Consequence To Patient 3 3
Pain 3 3
Radiation Exposure, Unintended 2 2
Syncope 1 1
Complaint, Ill-Defined 1 1
Electric Shock 1 1
Dizziness 1 1
No Information 1 1
Cardiac Arrest 1 1
Irritation 1 1
Fall 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Skin Tears 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems, SCS II Feb-08-2024
2 Hologic, Inc. II Feb-18-2020
3 Siemens Medical Solutions USA, Inc II Jun-16-2020
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