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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
COOPER SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS LUNAR
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
  SUBSTANTIALLY EQUIVALENT 1
HEARTLUNG CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
LONE OAK MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAPS GROUP SA
  SUBSTANTIALLY EQUIVALENT 2
MINDWAYS SOFTWARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
O.N. DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 2 2
2016 1 1
2017 16 16
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 10 10
Poor Quality Image 8 8
Device Stops Intermittently 5 5
Defective Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Display/Image 1 1
Use of Device Problem 1 1
Unintended Movement 1 1
Device Maintenance Issue 1 1
Patient Data Problem 1 1
Mechanics Altered 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Computer Software Problem 1 1
Noise, Audible 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Not Applicable 21 21
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Bone Fracture(s) 1 1
No Code Available 1 1
Unintended Radiation Exposure 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cooper Surgical, Inc. II Nov-18-2011
2 GE Healthcare, LLC II Apr-24-2020
3 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Apr-17-2018
4 Ge Healthcare II Jan-27-2010
5 Hologic, Inc. II Aug-25-2009
6 Medimaps Group II Nov-05-2016
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