Home / 510(k) Clearances / K993708

510(k) K993708

BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG by Biomagnetic Technologies, Inc. — Product Code OLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1999
Date Received
November 3, 1999
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 Biomagnetic Technologies, Inc.

  • K962317 — MAGNES 2500 WH BIOMAGNETOMETER (May 7, 1997)
  • K941553 — MAGNES II BIOMAGNETOMETER (May 16, 1996)
  • K921821 — IBT MODEL SVI (November 2, 1992)
  • K913604 — SOMATOSENSORY STIMULUS SYSTEM (December 9, 1991)
  • K901215 — 700 SERIES BIOMAGNETOMETER (June 25, 1990)
  • K854466 — BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER (February 4, 1986)
  • K790031 — GENERATOR, BIOTEC 876 PULSE (January 2, 1979)

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)