TPLC - Total Product Life Cycle

• Device: non-normalizing quantitative electroencephalograph software
• Regulation Description: Electroencephalograph.
• Definition: Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
• Product Code: OLT
• Regulation Number: 882.1400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
GE HEALTHCARE FINLAND OY
	SUBSTANTIALLY EQUIVALENT	1
HIPPOCLINIC
	SUBSTANTIALLY EQUIVALENT	1
NEUROSERVO, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROSOFT , LTD.
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PASCALL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	1	1
2021	6	6
2022	4	4
2023	5	5
2024	4	4
2025	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Application Program Problem	6	6
Overheating of Device	4	4
Temperature Problem	4	4
Output Problem	3	3
No Audible Alarm	3	3
Alarm Not Visible	3	3
Protective Measures Problem	3	3
Application Program Freezes, Becomes Nonfunctional	3	3
Smoking	2	2
Structural Problem	2	2
Power Problem	2	2
Display or Visual Feedback Problem	2	2
Device Tipped Over	1	1
Unintended Movement	1	1
Unintended Application Program Shut Down	1	1
Inaccurate Information	1	1
Failure to Deliver Shock/Stimulation	1	1
Electrical /Electronic Property Problem	1	1
Unintended Collision	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Tissue Injury	2	2