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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device densitometer/scanner (integrating, reflectance, tlc, radiochromat.) clinica
Product CodeJQT
Regulation Number 862.2400
Device Class 1


Premarket Reviews
ManufacturerDecision
ARLINGTON SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 3 3
2019 5 5
2020 11 11
2021 5 5
2022 5 5
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 15 15
Sparking 13 13
Noise, Audible 4 4
Unintended Electrical Shock 3 3
Smoking 3 3
Electro-Static Discharge 3 3
Failure to Power Up 3 3
Inappropriate/Inadequate Shock/Stimulation 1 1
Fire 1 1
Overheating of Device 1 1
Device Markings/Labelling Problem 1 1
Electrical Overstress 1 1
Fail-Safe Problem 1 1
Power Problem 1 1
Temperature Problem 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
No Known Impact Or Consequence To Patient 7 7
Electric Shock 5 5
No Consequences Or Impact To Patient 2 2
No Code Available 1 1
Insufficient Information 1 1
Numbness 1 1
Pain 1 1

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