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510(k) Data Aggregation
K Number
K131882Device Name
GEODESICEEG SYSTEM 400 SERIES (GES 400)
Manufacturer
ELECTRICAL GEODESICS, INC.
Date Cleared
2014-02-12
(232 days)
Product Code
OLT, GWQ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
ELECTRICAL GEODESICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Geodesic EEG System 400 Series™ (GES 400) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
Device Description
The Geodesic EEG System™ 400 Series (GES 400) is a digital electroencephalograph system (EEG). Each system consists of an amplifier, central processing unit, software, electrodes, and components of a standard personal computer (monitor, keyboard, and mouse). The GES 400 Series consists of 3 models (GES 400, GES 405, and GES 410), each of which has a slightly different amplifier. The amplifiers are very similar and all are called Net Amps ". They vary in connectors used to attach the electrodes and in the A/D chips, which support different maximum sampling rates. The other parts of the GES 400 Series are identical and consist of an isolation transformer, a power supply, Net Station software, proprietary EEG electrodes, and data acquisition computer. Optional accessories include a cart that holds the components of the system, interface cable, and articulated arm. The GES 400 Series also accepts third party DIN 42802 electrodes and an SpO22 electrode.
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K Number
K112353Device Name
GEODESIC EEG MOBILE 100 (GEM 100)
Manufacturer
ELECTRICAL GEODESICS, INC.
Date Cleared
2012-02-17
(185 days)
Product Code
GWQ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
ELECTRICAL GEODESICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Geodesic EEG Mobile 100 (GEM 100) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
Device Description
The Geodesic EEG Mobile 100 (GEM 100) is a digital electroencephalograph system (EEG). It consists of an amplifier, two adapters, central processing unit, software, electrodes, isolation transformer, and components of a standard personal computer (monitor, keyboard, and mouse). Integral components allow wireless communication.
The GEM 100 has 4 configurations. These are based on the type of EEG electrodes that will be used and the environment for use. The Neurotravel software is used to acquire, record, and archive the data from all 4 configurations. These configurations are:
- Ambulatory EEG only .
- Ambulatory EEG with conventional electrodes and physiological sensors ●
- Stationary (in-clinic) EEG only .
- Stationary (in-clinic) EEG with conventional electrodes and physiological sensors .
The GEM 100 EEG Amplifier is used with all configurations, but the other components vary depending on the requirements of the patient and physician. Accessories that can be used with the GEM 100 include: Sensor Kit for SpO2, LTM Net Support Kit, Video EEG, photic stimulator, TTL patient event switch, laser or inkjet printer, mobile cart, and ambulatory pouch.
The GEM 100 operates like other digital electroencephalographs. It can run on mains power or on battery power. Data can be recorded to a CompactFlash card or to the system computer. Data can be transmitted by USB connection or by Bluetooth or can be transferred from the Compact Flash card to the system computer.
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K Number
K092844Device Name
GEOSOURCE
Manufacturer
ELECTRICAL GEODESICS, INC.
Date Cleared
2010-12-21
(462 days)
Product Code
OLX
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
ELECTRICAL GEODESICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GeoSource is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an idealized head model and an idealized MRI image.
Device Description
GeoSource is an add-on software module to EGI's Net Station software and can only be used on EEG data generated by EGI hardware. It runs on a personal computer. It is used to approximate source localization of EEG signals and visualize those estimated locations. It uses the linear inverse methods LORETA, LAURA, and sLORETA and the sphere and Finite Difference forward head models.
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