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510(k) K092844

GEOSOURCE by Electrical Geodesics, Inc. — Product Code OLX

K092844 is an FDA 510(k) premarket notification submitted by Electrical Geodesics, Inc. for the device "GEOSOURCE". The FDA issued a decision of Substantially Equivalent on December 21, 2010. The device falls under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph), a Class II device regulated under 21 CFR 882.1400. Electrical Geodesics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2010
Date Received
September 15, 2009
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

Other clearances by Electrical Geodesics, Inc.

  • K131882 — GEODESICEEG SYSTEM 400 SERIES (GES 400) (February 12, 2014)
  • K112353 — GEODESIC EEG MOBILE 100 (GEM 100) (February 17, 2012)

Other clearances for product code OLX

  • K260563 — CN-Suite™ (August 16, 2026)
  • K252565 — PreOp v3 (February 13, 2026)
  • K250239 — NeuroMatch (May 23, 2025)
  • K241513 — Sourcerer (September 27, 2024)
  • K233985 — TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) (May 15, 2024)
  • K210199 — RICOH MEG (July 2, 2021)
  • K201910 — EZTrack (December 22, 2020)
  • K172858 — PreOp (January 8, 2018)
  • K100126 — STELLATE GRIDVIEW (December 3, 2010)
  • K091393 — ELEKTA NEUROMAG WITH MAXFILTER (October 26, 2010)

FDA data resources