Product Code: OLX FDA class 2 21 CFR 882.1400

Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Neurology

The Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It correlates electrical activity of the brain using various neuroimaging modalities to perform source-localization, helping identify the anatomical origin of brain electrical activity. 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

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OLX
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

—

Summary Malfunction Reporting

Definition

Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252565	PreOp v3	Feb 13, 2026	Substantially Equivalent	Clouds of Care
K250239	NeuroMatch	May 23, 2025	Substantially Equivalent	LVIS Corporation
K241513	Sourcerer	Sep 27, 2024	Substantially Equivalent	Brain Electrophysiology Laboratory Company, LLC
K233985	TRIUX neo (NM27000N ); MEGreview (SW26241N-B)	May 15, 2024	Substantially Equivalent	Megin OY
K210199	RICOH MEG	Jul 02, 2021	Substantially Equivalent	Ricoh Company, Ltd.
K201910	EZTrack	Dec 22, 2020	Substantially Equivalent	Neurologic, LLC
K172858	PreOp	Jan 08, 2018	Substantially Equivalent	Epilog
K092844	GEOSOURCE	Dec 21, 2010	Substantially Equivalent	Electrical Geodesics, Inc.
K100126	STELLATE GRIDVIEW	Dec 03, 2010	Substantially Equivalent	Excel-Tech Ltd. (Xltek)
K091393	ELEKTA NEUROMAG WITH MAXFILTER	Oct 26, 2010	Substantially Equivalent	Elekta Neuromag OY
K081430	ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING	Jul 28, 2008	Substantially Equivalent	Elekta Neuromag OY
K070358	MAXINSIGHT	Jul 30, 2007	Substantially Equivalent	Eemagine Medical Imaging Solutions GmbH
K050035	ELEKTA NEUROMAG WITH MAXWELL FILTER	Jan 25, 2005	Substantially Equivalent	Elekta Neuromag OY
K041264	ELEKTA OY	Aug 10, 2004	Substantially Equivalent	Elekta Neuromag OY
K040051	MEGVISION, MODEL EQ1000C SERIES	Mar 24, 2004	Substantially Equivalent	Eagle Technology, Inc.
K030737	OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275	Oct 10, 2003	Substantially Equivalent	Ctf Systems (2001), Inc.
K011241	NEUROSOFT'S SOURCE	Sep 19, 2001	Substantially Equivalent	Neurosoft, Inc.
K001781	CURRY MULTIMODAL NEUROIMAGING SOFTWARE	Feb 05, 2001	Substantially Equivalent	Neurosoft, Inc.
K002631	ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG	Oct 23, 2000	Substantially Equivalent	Eemagine Medical Imaging Solutions GmbH
K993708	BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG	Dec 03, 1999	Substantially Equivalent	Biomagnetic Technologies, Inc.
K984401	NEUROMAG VECTORVIEW	Dec 30, 1998	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K980477	IMAGE VUE EEG	Aug 06, 1998	Substantially Equivalent	Sam Technology, Inc.
K941553	MAGNES II BIOMAGNETOMETER	May 16, 1996	Substantially Equivalent	Biomagnetic Technologies, Inc.
K901215	700 SERIES BIOMAGNETOMETER	Jun 25, 1990	Substantially Equivalent	Biomagnetic Technologies, Inc.