Home / 510(k) Clearances / K030737

510(k) K030737

OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 by Ctf Systems (2001), Inc. — Product Code OLX

K030737 is an FDA 510(k) premarket notification submitted by Ctf Systems (2001), Inc. for the device "OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275". The FDA issued a decision of Substantially Equivalent on October 10, 2003. The device falls under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph), a Class II device regulated under 21 CFR 882.1400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2003
Date Received
March 10, 2003
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 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