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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
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
  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
2021 1 1
2022 1 1
2023 2 2
2024 2 2
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Electrical Shock 3 3
Device Handling Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Sparking 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Insufficient Information 3 3
Bone Fracture(s) 1 1
Blister 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hologic Inc II Jul-16-2024
2 Medimaps Group II Feb-28-2025
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