Product Code: OLU FDA class 2 21 CFR 882.1400

Normalizing Quantitative Electroencephalograph Software

Neurology

The Normalizing Quantitative Electroencephalograph Software (product code OLU) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It performs post-hoc statistical analysis of electroencephalograph signals and compares results against a normative database for interpretation by a qualified user, distinguishing it from non-normalizing EEG software. The device is eligible for third-party review and is not an implant or life-sustaining device.

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510(k)s

FEI Numbers

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Basic Information

Product Code: OLU
Device Class: FDA class 2
Regulation Number: 882.1400
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

Definition

Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253015	Cognitive Function Neuroimaging (cfNI) Software (1.0.0)	Jun 12, 2026	Substantially Equivalent	VoxNeuro, Inc.
K240420	NeuroField Analysis Suite	Sep 20, 2024	Substantially Equivalent	Neurofield, Inc.
K222838	iSyncBrain©-C	Mar 16, 2023	Substantially Equivalent	iMediSync, Inc.
K212684	BrainView QEEG Software	Jan 28, 2023	Substantially Equivalent	Medeia, Inc.
K202588	BNA Platform	Dec 07, 2020	Substantially Equivalent	Elminda, Ltd.
K191432	cortiQ PRO	Jan 24, 2020	Substantially Equivalent	G.Tec Medical Engineering GmbH
K171414	qEEG-Pro	Jul 01, 2018	Substantially Equivalent	Brainmaster Technologies, Inc.
K121119	BNA ANALYSIS SYSTEM	Jul 25, 2014	Substantially Equivalent	Eiminda , Ltd.
K112077	HBIDB - HUMAN BRIAN INDEX SOFTWARE	Mar 09, 2012	Substantially Equivalent	Corscience GmbH & Co. KG
K050192	BRC SOFTWARE PRODUCT	Oct 20, 2005	Substantially Equivalent	Brc Operations Pty Limited
K041263	NEUROGUIDE ANALYSIS SYSTEM	Aug 03, 2004	Substantially Equivalent	Applied Neuroscience, Inc.
K974748	NEUROMETRIC ANALYSIS SYSTEM	Jul 10, 1998	Substantially Equivalent	Nxlink, Ltd.
K904294	QSI 9500	Jul 30, 1991	Substantially Equivalent	Quantified Signal Imaging, Inc.