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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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 112 112
Break 13 13
Use of Device Problem 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Unintended Movement 5 5
Insufficient Information 3 3
Device Operational Issue 3 3
Unintended Collision 2 2
Positioning Problem 2 2
No Apparent Adverse Event 2 2
Device Handling Problem 2 2
Fire 2 2
Mechanical Problem 2 2
Mechanical Jam 2 2
Melted 1 1
Fracture 1 1
Labelling, Instructions for Use or Training Problem 1 1
Crack 1 1
Material Disintegration 1 1
Display or Visual Feedback Problem 1 1
Material Erosion 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Structural Problem 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Detachment of Device or Device Component 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Unintended Electrical Shock 1 1
Data Problem 1 1
Patient Data Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Output Problem 1 1
Device Alarm System 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 116 116
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
Liver Failure 1 1
Complaint, Ill-Defined 1 1
Syncope 1 1
Electric Shock 1 1
No Information 1 1
Dizziness 1 1
Cardiac Arrest 1 1
Irritation 1 1
Jaundice 1 1
Fall 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Skin Tears 1 1
Cancer 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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