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510(k) K081430

ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING by Elekta Neuromag OY — Product Code OLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2008
Date Received
May 21, 2008
Clearance Type
Special
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 Elekta Neuromag OY

  • K091393 — ELEKTA NEUROMAG WITH MAXFILTER (October 26, 2010)
  • K050035 — ELEKTA NEUROMAG WITH MAXWELL FILTER (January 25, 2005)
  • K041264 — ELEKTA OY (August 10, 2004)

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)