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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device densitometer, bone
Regulation Description Bone densitometer.
Product CodeKGI
Regulation Number 892.1170
Device Class 2


Premarket Reviews
ManufacturerDecision
3D-SHAPER MEDICAL S.L
  SUBSTANTIALLY EQUIVALENT 2
BUNKERHILL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
HEARTLUNG CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAPS GROUP SA
  SUBSTANTIALLY EQUIVALENT 1
O.N. DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 1 1
2022 1 1
2023 2 2
2024 2 2
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Electrical Shock 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Sparking 1 1
No Display/Image 1 1
Fire 1 1
Mechanical Problem 1 1
Fail-Safe Did Not Operate 1 1
Defective Component 1 1
Defective Device 1 1
Mechanics Altered 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure of Device to Self-Test 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 8 8
Insufficient Information 4 4
Blister 1 1
No Known Impact Or Consequence To Patient 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Apr-24-2020
2 Hologic Inc II Jul-16-2024
3 Medimaps Group II Feb-28-2025
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