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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
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN
  SUBSTANTIALLY EQUIVALENT 1
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAPS GROUP SA
  SUBSTANTIALLY EQUIVALENT 1
MINDWAYS SOFTWARE, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Displays Incorrect Message 9
Poor Quality Image 8
Device Stops Intermittently 5
Use of Device Problem 1
Adverse Event Without Identified Device or Use Problem 1
Computer Software Problem 1
Total Device Problems 25

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Apr-17-2018
2 Medimaps Group II Nov-05-2016

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