FDA.reportPublic FDA data

GeoSource

Primary DI
00863003000343
Brand
GeoSource
Company
ELECTRICAL GEODESICS, INC.
Model
GeoSource 2.0
Device description
Source Localization Software For Electroencephalograph Or Magnetoencephalograph Electroencephalograph.
Published
2016-10-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLXSource Localization Software For Electroencephalograph Or MagnetoencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863003000343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863003000343008630030003438630030003430863003000343

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
541-687-7962supportteam@egi.com

Regulatory Flags#

DUNS number
809845365
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863003000305 Geodesic EEG SystemGES 400 Series 2016-10-03
00863003000312Geodesic Photogrammetry SystemGPS 3.02016-10-04
00863003000329HydroCel Geodesic Sensor Net HCGSN 1302016-10-04
00863003000336MicroCel Geodesic Sensor Net MCGSN 100 Series2016-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056774017NeuroMatchLVIS CORPORATIONOLX2026-05-12
05430000733038Persyst ESI powered by EpilogClouds of CareOLX2026-04-20
09342451002433Compumedics CurryCOMPUMEDICS LIMITEDOLX2026-03-12
00860008953100SourcererBrain Electrophysiology Laboratory Company, LLCOLX2025-10-20
06430056480404MEGreview™Megin OyOLX2025-05-23
06430056480411TRIUX™ neoMegin OyOLX2025-05-23
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpOLX2023-07-24
05430000733045Persyst ESI powered by EpilogClouds of CareOLX2023-06-14
05430000733021PreOpClouds of CareOLX2022-06-22
00850033571028GeoSource 2.0 Source Estimation SoftwareMagstim, Inc.OLX2022-01-25
05430000733007PreOp Clouds of CareOLX2020-10-01
04961311926266RICOH MEGRICOH COMPANY,LTD.OLX2018-03-07
06430056480008Elekta Neuromag® TRIUXMegin OyOLX2016-09-23
06430056480015Elekta Neuromag® TRIUXMegin OyOLX2016-09-23
06430056480022Data analysis software 3.4Megin OyOLX2016-09-23