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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device non-normalizing quantitative electroencephalograph software
Definition Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
Product CodeOLT
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINSCOPE COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
EB NEURO, S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ELECTRICAL GEODESICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 1
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
KVIKNA EHF
  SUBSTANTIALLY EQUIVALENT 2
MOBERG RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEURONETRIX SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
NEUROSOFT LTD
  SUBSTANTIALLY EQUIVALENT 1
NEUROSOFT LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUROWAVE SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
PASCALL SYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2018 7 7
2019 2 2
2020 1 1
2021 6 6
2022 4 4
2023 5 5
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Problem 6 6
Temperature Problem 5 5
Smoking 5 5
Overheating of Device 4 4
No Audible Alarm 3 3
Alarm Not Visible 3 3
Display or Visual Feedback Problem 3 3
Protective Measures Problem 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Appropriate Term/Code Not Available 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 2 2
Power Problem 2 2
Structural Problem 2 2
Device Tipped Over 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Unintended Movement 1 1
Mechanical Problem 1 1
Unintended Collision 1 1
Failure to Power Up 1 1
Device Stops Intermittently 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 3 3
Death 2 2
Unspecified Tissue Injury 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Information 1 1
Patient Problem/Medical Problem 1 1

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