FDA Product Code OLU: Normalizing Quantitative Electroencephalograph Software
Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A Qualified User.
Leading manufacturers include Applied Neuroscience, Inc., Brc Operations Pty Limited and Corscience GmbH & Co. KG.
13
Total
13
Cleared
297d
Avg days
1991
Since
Declining activity -
1 submissions in the last 2 years
vs 3 in the prior period
Consistent review times:
266d avg (recent)
FDA 510(k) Cleared Normalizing Quantitative Electroencephalograph Software Devices (Product Code OLU)
13 devices
Cleared
Jun 12, 2026
Cognitive Function Neuroimaging (cfNI) Software (1.0.0)
VoxNeuro, Inc.
Neurology
266d
Cleared
Sep 20, 2024
NeuroField Analysis Suite
Neurofield, Inc.
Neurology
220d
Cleared
Mar 16, 2023
iSyncBrain©-C
iMediSync, Inc.
Neurology
177d
Cleared
Jan 28, 2023
BrainView QEEG Software
Medeia, Inc.
Neurology
522d
Cleared
Dec 07, 2020
BNA Platform
Elminda, Ltd.
Neurology
90d
Cleared
Jan 24, 2020
cortiQ PRO
G.Tec Medical Engineering GmbH
Neurology
240d
Cleared
Jul 01, 2018
qEEG-Pro
Brainmaster Technologies, Inc.
Neurology
412d
Cleared
Jul 25, 2014
BNA ANALYSIS SYSTEM
Eiminda , Ltd.
Neurology
834d
Cleared
Mar 09, 2012
HBIDB - HUMAN BRIAN INDEX SOFTWARE
Corscience GmbH & Co. KG
Neurology
232d
Cleared
Oct 20, 2005
BRC SOFTWARE PRODUCT
Brc Operations Pty Limited
Neurology
266d
Cleared
Aug 03, 2004
NEUROGUIDE ANALYSIS SYSTEM
Applied Neuroscience, Inc.
Neurology
84d
Cleared
Jul 10, 1998
NEUROMETRIC ANALYSIS SYSTEM
Nxlink, Ltd.
Neurology
203d
About Product Code OLU - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code OLU since 1991, with 13 receiving FDA clearance (average review time: 297 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - OLU Product Code
FDA review times for OLU submissions have been consistent, averaging 266 days recently vs 300 days historically.
OLU devices are reviewed by the Neurology panel. Browse all Neurology devices →