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510(k) K002631

ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG by Eemagine Medical Imaging Solutions GmbH — Product Code OLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2000
Date Received
August 23, 2000
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 Eemagine Medical Imaging Solutions GmbH

  • K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (November 25, 2024)
  • K210109 — visor2 system (April 8, 2022)
  • K192889 — Neo (January 30, 2020)
  • K172312 — eego amplifiers (March 30, 2018)
  • K110223 — WAVEGUARD (TM) EEG CAP (June 29, 2011)
  • K070358 — MAXINSIGHT (July 30, 2007)
  • K051825 — COGNITRACE (September 12, 2005)

Other clearances for product code OLX

  • 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)
  • K092844 — GEOSOURCE (December 21, 2010)
  • K100126 — STELLATE GRIDVIEW (December 3, 2010)
  • K091393 — ELEKTA NEUROMAG WITH MAXFILTER (October 26, 2010)