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TPLC - Total Product Life Cycle
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Device automatic event detection software for full-montage electroencephalograph
Definition Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
Product CodeOMB
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
AIT AUSTRIAN INSTITUTE OF TECHNOLOGY GMBH
  SUBSTANTIALLY EQUIVALENT 1
AUSTRIAN INSTITUTE OF TECHNOLOGY GMBH
  SUBSTANTIALLY EQUIVALENT 1
CADWELL
  SUBSTANTIALLY EQUIVALENT 1
CERIBELL, INC.
  SUBSTANTIALLY EQUIVALENT 2
EPITEL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
HOLBERG EEG AS
  SUBSTANTIALLY EQUIVALENT 1
LVIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 2
NATUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPTIMA NEUROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
PERSYST DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
PERSYST DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
PICOFEMTO LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2022 1 1
2023 3 3
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 8 8
Unintended Movement 6 6
Break 2 2
Sparking 2 2
Communication or Transmission Problem 1 1
Material Twisted/Bent 1 1
Power Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Device Alarm System 1 1
Low Audible Alarm 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Known Impact Or Consequence To Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cardiac Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Natus Neurology DBA Excel Tech., Ltd. (XLTEK) II Feb-22-2022
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