BrainView QEEG Software

Q: What is the product code of K212684?

The FDA product code is OLU – Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.

FDA 510(k) K212684 · Medeia, Inc.

Substantially Equivalent

510(k) numberK212684

Submission

Device name: BrainView QEEG Software
Applicant: Medeia, Inc.
Santa Barbara, CA, US
Received: August 24, 2021
Decision date: January 28, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OLU – Normalizing Quantitative Electroencephalograph Software
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1400
Specialty: Neurology

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

Other 510(k)s with product code OLU

510(k)	Device	Applicant	Decision
K253015	Cognitive Function Neuroimaging (cfNI) Software (1.0.0)OLU · Traditional	VoxNeuro, Inc.	06/12/2026SE
K240420	NeuroField Analysis SuiteOLU · Traditional	Neurofield, Inc.	09/20/2024SE
K222838	iSyncBrain©-COLU · Traditional	iMediSync, Inc.	03/16/2023SE
K202588	BNA PlatformOLU · Traditional	Elminda, Ltd.	12/07/2020SE
K191432	cortiQ PROOLU · Traditional	G.Tec Medical Engineering GmbH	01/24/2020SE
K171414	qEEG-ProOLU · Traditional	Brainmaster Technologies, Inc.	07/01/2018SE
K121119	Bna Analysis SystemOLU · Traditional	Eiminda , Ltd.	07/25/2014SE
K112077	Hbidb - Human Brian Index SoftwareOLU · Traditional	Corscience GmbH & Co. KG	03/09/2012SE
K050192	BRC Software ProductOLU · Traditional	Brc Operations Pty Limited	10/20/2005SE
K041263	Neuroguide Analysis SystemOLU · Traditional	Applied Neuroscience, Inc.	08/03/2004SE

More from Applied Neuroscience, Inc.

510(k)	Device	Decision
K192753	NeuralScan SystemGWQ · Traditional	03/17/2020SE
K191266	VitalScan ANSJOM · Traditional	01/15/2020SE
K150804	QBioScanGZO · Traditional	10/19/2015SE

Questions and answers

When was BrainView QEEG Software cleared by the FDA?

BrainView QEEG Software (K212684) received a 510(k) decision of Substantially Equivalent on January 28, 2023, 522 days after the submission was received.

What is the product code of K212684?

The FDA product code is OLU – Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.