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510(k) K172858

PreOp by Epilog — Product Code OLX

K172858 is an FDA 510(k) premarket notification submitted by Epilog for the device "PreOp". The FDA issued a decision of Substantially Equivalent on January 8, 2018. 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
January 8, 2018
Date Received
September 20, 2017
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 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)
  • K092844 — GEOSOURCE (December 21, 2010)
  • K100126 — STELLATE GRIDVIEW (December 3, 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