OLX · Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | OLX |
|---|---|
| Device Name | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252565 | PreOp v3 | Clouds of Care | Feb 13, 2026 | SESE |
| K250239 | NeuroMatch | LVIS Corporation | May 23, 2025 | SESE |
| K241513 | Sourcerer | Brain Electrophysiology Laboratory Company, LLC | Sep 27, 2024 | SESE |
| K233985 | TRIUX neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY | May 15, 2024 | SESE |
| K210199 | RICOH MEG | Ricoh Company, Ltd. | Jul 2, 2021 | SESE |
| K201910 | EZTrack | Neurologic, LLC | Dec 22, 2020 | SESE |
| K172858 | PreOp | Epilog | Jan 8, 2018 | SESE |
| K092844 | GEOSOURCE | Electrical Geodesics, Inc. | Dec 21, 2010 | SESE |
| K100126 | STELLATE GRIDVIEW | Excel-Tech Ltd. (Xltek) | Dec 3, 2010 | SESE |
| K091393 | ELEKTA NEUROMAG WITH MAXFILTER | Elekta Neuromag OY | Oct 26, 2010 | SESE |
| K081430 | ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING | Elekta Neuromag OY | Jul 28, 2008 | SESE |
| K070358 | MAXINSIGHT | Eemagine Medical Imaging Solutions GmbH | Jul 30, 2007 | SESE |
| K050035 | ELEKTA NEUROMAG WITH MAXWELL FILTER | Elekta Neuromag OY | Jan 25, 2005 | SESE |
| K041264 | ELEKTA OY | Elekta Neuromag OY | Aug 10, 2004 | SESE |
| K040051 | MEGVISION, MODEL EQ1000C SERIES | Eagle Technology, Inc. | Mar 24, 2004 | SESE |
| K030737 | OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 | Ctf Systems (2001), Inc. | Oct 10, 2003 | SESE |
| K011241 | NEUROSOFT'S SOURCE | Neurosoft, Inc. | Sep 19, 2001 | SESE |
| K001781 | CURRY MULTIMODAL NEUROIMAGING SOFTWARE | Neurosoft, Inc. | Feb 5, 2001 | SESE |
| K002631 | ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG | Eemagine Medical Imaging Solutions GmbH | Oct 23, 2000 | SESE |
| K993708 | BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG | Biomagnetic Technologies, Inc. | Dec 3, 1999 | SESE |
Top Applicants
- Elekta Neuromag OY — 4 clearances
- Biomagnetic Technologies, Inc. — 3 clearances
- Eemagine Medical Imaging Solutions GmbH — 2 clearances
- Neurosoft, Inc. — 2 clearances
- Brain Electrophysiology Laboratory Company, LLC — 1 clearance
