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510(k) K100126

STELLATE GRIDVIEW by Excel-Tech Ltd. (Xltek) — Product Code OLX

K100126 is an FDA 510(k) premarket notification submitted by Excel-Tech Ltd. (Xltek) for the device "STELLATE GRIDVIEW". The FDA issued a decision of Substantially Equivalent on December 3, 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. Excel-Tech Ltd. (Xltek) has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2010
Date Received
January 19, 2010
Clearance Type
Abbreviated
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 Excel-Tech Ltd. (Xltek)

  • K131266 — TREZ_HD (February 14, 2014)
  • K123079 — OLYMPIC BRAINZ MONITOR (May 8, 2013)
  • K120260 — ICTA (June 29, 2012)
  • K090277 — NATUS SLEEPWORKS, MODEL 104017 (April 19, 2011)
  • K081741 — NEUROLINK IP, MODEL PK1113 (October 31, 2008)

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)
  • K091393 — ELEKTA NEUROMAG WITH MAXFILTER (October 26, 2010)
  • K081430 — ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING (July 28, 2008)

FDA data resources