510(k) K070358

MAXINSIGHT by Eemagine Medical Imaging Solutions GmbH — Product Code OLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2007
Date Received
February 7, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization