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510(k) Data Aggregation
K Number
K040051Device Name
MEGVISION, MODEL EQ1000C SERIES
Manufacturer
EAGLE TECHNOLOGY, INC.
Date Cleared
2004-03-24
(72 days)
Product Code
OLX, OLY
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
EAGLE TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MEGvision is intended for use as a magnetoencephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.
Device Description
The MEGvision integrates up to 320 dc-SQUID axial gradiometer with PCs and data acquisition software in order to measure the magnetic signals generated by the intercellular dendritic currents. These detectors positioned in a helmet shaped array give the user the ability to record the electrical activity of the entire surface of the brain cortex simultaneously without having to move the position of the sensor array.
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