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510(k) K050035

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

K050035 is an FDA 510(k) premarket notification submitted by Elekta Neuromag OY for the device "ELEKTA NEUROMAG WITH MAXWELL FILTER". The FDA issued a decision of Substantially Equivalent on January 25, 2005. The device falls under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph), a Class II device regulated under 21 CFR 882.1400. Elekta Neuromag OY has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2005
Date Received
January 7, 2005
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)
  • K081430 — ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING (July 28, 2008)
  • K041264 — ELEKTA OY (August 10, 2004)

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)
  • K092844 — GEOSOURCE (December 21, 2010)
  • K100126 — STELLATE GRIDVIEW (December 3, 2010)

FDA data resources