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Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Page Type
Product Code
Definition
Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
Physical State
Software algorithm. Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software used as the only or final electroencephalograph analysis step, electroencephalograph software with comparative databases (normal or otherwise) or electroencephalograph software that outputs an index, diagnosis, or classification.
Technical Method
Uses software algorithms that correlate the electroencephalograph to one or several types of neuroimaging data. May include use of event-detection algorithms (that require user confirmation) as an intermediary, but not final, step.
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
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).

Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Page Type
Product Code
Definition
Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
Physical State
Software algorithm. Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software used as the only or final electroencephalograph analysis step, electroencephalograph software with comparative databases (normal or otherwise) or electroencephalograph software that outputs an index, diagnosis, or classification.
Technical Method
Uses software algorithms that correlate the electroencephalograph to one or several types of neuroimaging data. May include use of event-detection algorithms (that require user confirmation) as an intermediary, but not final, step.
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
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).