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Automatic Event Detection Software For Full-Montage Electroencephalograph

Page Type
Product Code
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
Physical State
Electroencephalograph analysis software. Does NOT include electrodes, electroencephalograph hardware, basic electroencephalograph software (e.g. used to display, store, archive, or manually annotate data), or automatic event detection software used as an intermediary step in source-localization analysis.
Technical Method
Uses software algorithms to analyze full-montage electroencephalograph (16 electrodes) at user-specified locations and automatically identify areas of interest.
Target Area
Brain
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1400
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1400 Electroencephalograph

§ 882.1400 Electroencephalograph.

(a) Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

(b) Classification. Class II (performance standards).

Automatic Event Detection Software For Full-Montage Electroencephalograph

Page Type
Product Code
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
Physical State
Electroencephalograph analysis software. Does NOT include electrodes, electroencephalograph hardware, basic electroencephalograph software (e.g. used to display, store, archive, or manually annotate data), or automatic event detection software used as an intermediary step in source-localization analysis.
Technical Method
Uses software algorithms to analyze full-montage electroencephalograph (16 electrodes) at user-specified locations and automatically identify areas of interest.
Target Area
Brain
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1400
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1400 Electroencephalograph

§ 882.1400 Electroencephalograph.

(a) Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

(b) Classification. Class II (performance standards).