OLX · Class II · 21 CFR 882.1400

FDA Product Code OLX: Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization

Leading manufacturers include Elekta Neuromag OY, Biomagnetic Technologies, Inc. and Neurosoft, Inc..

25
Total
25
Cleared
188d
Avg days
1990
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 159d recently vs 191d historically

FDA 510(k) Cleared Source Localization Software For Electroencephalograph Or Magnetoencephalograph Devices (Product Code OLX)

25 devices
1–24 of 25
Cleared Aug 16, 2026
CN-Suite™
K260563
FIND Surgical Sciences Inc. D/B/A FIND Neuro
Neurology · 178d
Cleared Feb 13, 2026
PreOp v3
K252565
Clouds of Care
Neurology · 183d
Cleared May 23, 2025
NeuroMatch
K250239
LVIS Corporation
Neurology · 116d
Cleared Sep 27, 2024
Sourcerer
K241513
Brain Electrophysiology Laboratory Company, LLC
Neurology · 121d
Cleared May 15, 2024
TRIUX™ neo (NM27000N )
K233985
Megin OY
Neurology · 149d
Cleared Jul 02, 2021
RICOH MEG
K210199
Ricoh Company, Ltd.
Neurology · 158d
Cleared Dec 22, 2020
EZTrack
K201910
Neurologic, LLC
Neurology · 166d
Cleared Jan 08, 2018
PreOp
K172858
Epilog
Neurology · 110d
Cleared Dec 21, 2010
GEOSOURCE
K092844
Electrical Geodesics, Inc.
Neurology · 462d
Cleared Dec 03, 2010
STELLATE GRIDVIEW
K100126
Excel-Tech Ltd. (Xltek)
Radiology · 318d
Cleared Oct 26, 2010
ELEKTA NEUROMAG WITH MAXFILTER
K091393
Elekta Neuromag OY
Neurology · 533d
Cleared Jul 28, 2008
ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING
K081430
Elekta Neuromag OY
Neurology · 68d
Cleared Jul 30, 2007
MAXINSIGHT
K070358
Eemagine Medical Imaging Solutions GmbH
Neurology · 173d
Cleared Jan 25, 2005
ELEKTA NEUROMAG WITH MAXWELL FILTER
K050035
Elekta Neuromag OY
Neurology · 18d
Cleared Aug 10, 2004
ELEKTA OY
K041264
Elekta Neuromag OY
Neurology · 90d
Cleared Mar 24, 2004
MEGVISION, MODEL EQ1000C SERIES
K040051
Eagle Technology, Inc.
Neurology · 72d
Cleared Oct 10, 2003
OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
K030737
Ctf Systems (2001), Inc.
Neurology · 214d
Cleared Sep 19, 2001
NEUROSOFT'S SOURCE
K011241
Neurosoft, Inc.
Neurology · 149d
Cleared Feb 05, 2001
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
K001781
Neurosoft, Inc.
Neurology · 237d
Cleared Oct 23, 2000
ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
K002631
Eemagine Medical Imaging Solutions GmbH
Neurology · 61d
Cleared Dec 03, 1999
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
K993708
Biomagnetic Technologies, Inc.
Neurology · 30d
Cleared Dec 30, 1998
NEUROMAG VECTORVIEW
K984401
Philips Medical Systems (Cleveland), Inc.
Neurology · 21d
Cleared Aug 06, 1998
IMAGE VUE EEG
K980477
Sam Technology, Inc.
Neurology · 181d
Cleared May 16, 1996
MAGNES II BIOMAGNETOMETER
K941553
Biomagnetic Technologies, Inc.
Neurology · 778d

About Product Code OLX - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code OLX since 1990, with 25 receiving FDA clearance (average review time: 188 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OLX Product Code

Recent submissions under OLX have taken an average of 159 days to reach a decision - down from 191 days historically, suggesting improved FDA processing for this classification.

OLX devices are reviewed by the Neurology panel. Browse all Neurology devices →