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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 2
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
METALTRONICA SPA
  SUBSTANTIALLY EQUIVALENT 1
PLANMED OY
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VMI TECNOLOGIAS LTDA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 25 25
2022 36 36
2023 29 29
2024 33 33
2025 40 40
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 103 103
Break 11 11
Adverse Event Without Identified Device or Use Problem 7 7
Unintended Movement 5 5
Use of Device Problem 4 4
Detachment of Device or Device Component 4 4
Device Operational Issue 4 4
Fire 2 2
Unintended Collision 2 2
Improper or Incorrect Procedure or Method 2 2
Mechanical Jam 2 2
Positioning Problem 2 2
Insufficient Information 2 2
Display or Visual Feedback Problem 1 1
Material Erosion 1 1
Fracture 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Melted 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Defective Component 1 1
Device Displays Incorrect Message 1 1
Material Integrity Problem 1 1
Optical Problem 1 1
Data Problem 1 1
Patient Data Problem 1 1
Device Handling Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 133 133
Insufficient Information 13 13
Laceration(s) 4 4
Bone Fracture(s) 3 3
Pain 2 2
Cancer 2 2
Liver Failure 1 1
Abdominal Pain 1 1
Melena 1 1
Electric Shock 1 1
Radiation Exposure, Unintended 1 1
Brain Injury 1 1
Fungal Infection 1 1
Dizziness 1 1
Cardiac Arrest 1 1
Intracranial Hemorrhage 1 1
Jaundice 1 1
Hematemesis 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Shock 1 1
Skin Tears 1 1
Hypoxia 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 1 1
Cerebral Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems, LLC II Dec-09-2025
2 GE Medical Systems, SCS II Feb-08-2024
3 Siemens Medical Solutions USA, Inc II Dec-03-2025
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