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TPLC
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Device
densitometer, bone
Product Code
KGI
Regulation Number
892.1170
Device Class
2
Premarket Reviews
Manufacturer
Decision
3D-SHAPER MEDICAL S.L
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
2020
2
2
2021
1
1
2022
1
1
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Display/Image
1
1
Mechanical Problem
1
1
Defective Component
1
1
Device Displays Incorrect Message
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
Insufficient Information
3
3
No Clinical Signs, Symptoms or Conditions
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
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