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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
3D-SHAPER MEDICAL S.L
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC
  SUBSTANTIALLY EQUIVALENT 1
HEARTLUNG CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
O.N. DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 6 6
2020 2 2
2021 1 1
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 4 4
Device Stops Intermittently 2 2
Defective Component 1 1
No Display/Image 1 1
Mechanical Problem 1 1
Poor Quality Image 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanics Altered 1 1
Therapeutic or Diagnostic Output Failure 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Not Applicable 6 6
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 1 1
Unintended Radiation Exposure 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Apr-24-2020
2 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Apr-17-2018
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