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 Epilog, Neurologic, LLC and Ricoh Company, Ltd..
24
Total
24
Cleared
188d
Avg days
1990
Since
Growing category -
3 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
140d
recently vs 195d historically
FDA 510(k) Cleared Source Localization Software For Electroencephalograph Or Magnetoencephalograph Devices (Product Code OLX)
24 devices
Cleared
Feb 13, 2026
PreOp v3
Clouds of Care
Neurology
183d
Cleared
May 23, 2025
NeuroMatch
LVIS Corporation
Neurology
116d
Cleared
Sep 27, 2024
Sourcerer
Brain Electrophysiology Laboratory Company, LLC
Neurology
121d
Cleared
May 15, 2024
TRIUX™ neo (NM27000N )
Megin OY
Neurology
149d
Cleared
Jul 02, 2021
RICOH MEG
Ricoh Company, Ltd.
Neurology
158d
Cleared
Dec 22, 2020
EZTrack
Neurologic, LLC
Neurology
166d
Cleared
Jan 08, 2018
PreOp
Epilog
Neurology
110d
Cleared
Dec 30, 1998
NEUROMAG VECTORVIEW
Philips Medical Systems (Cleveland), Inc.
Neurology
21d
About Product Code OLX - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code OLX since 1990, with 24 receiving FDA clearance (average review time: 188 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 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 140 days to reach a decision - down from 195 days historically, suggesting improved FDA processing for this classification.
OLX devices are reviewed by the Neurology panel. Browse all Neurology devices →