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 Elminda, Ltd., Medeia, Inc. and iMediSync, Inc..
13
Total
13
Cleared
297d
Avg days
1991
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg
243d
recently vs 307d historically
FDA 510(k) Cleared Normalizing Quantitative Electroencephalograph Software Devices (Product Code OLU)
13 devices
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
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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - OLU Product Code
Recent submissions under OLU have taken an average of 243 days to reach a decision - down from 307 days historically, suggesting improved FDA processing for this classification.
OLU devices are reviewed by the Neurology panel. Browse all Neurology devices →