OLX — Source Localization Software For Electroencephalograph Or Magnetoencephalograph Class II
FDA product code OLX covers "Source Localization Software For Electroencephalograph Or Magnetoencephalograph", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OLX
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252565 | clouds of care | PreOp v3 | February 13, 2026 |
| K250239 | lvis corporation | NeuroMatch | May 23, 2025 |
| K241513 | brain electrophysiology laboratory company | Sourcerer | September 27, 2024 |
| K233985 | megin | TRIUX neo (NM27000N ); MEGreview (SW26241N-B) | May 15, 2024 |
| K210199 | ricoh company | RICOH MEG | July 2, 2021 |
| K201910 | neurologic | EZTrack | December 22, 2020 |
| K172858 | epilog | PreOp | January 8, 2018 |
| K092844 | electrical geodesics | GEOSOURCE | December 21, 2010 |
| K100126 | excel-tech ltd. (xltek) | STELLATE GRIDVIEW | December 3, 2010 |
| K091393 | elekta neuromag | ELEKTA NEUROMAG WITH MAXFILTER | October 26, 2010 |
| K081430 | elekta neuromag | ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING | July 28, 2008 |
| K070358 | eemagine medical imaging solutions | MAXINSIGHT | July 30, 2007 |
| K050035 | elekta neuromag | ELEKTA NEUROMAG WITH MAXWELL FILTER | January 25, 2005 |
| K041264 | elekta neuromag | ELEKTA OY | August 10, 2004 |
| K040051 | eagle technology | MEGVISION, MODEL EQ1000C SERIES | March 24, 2004 |
| K030737 | ctf systems (2001) | OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 | October 10, 2003 |
| K011241 | neurosoft | NEUROSOFT'S SOURCE | September 19, 2001 |
| K001781 | neurosoft | CURRY MULTIMODAL NEUROIMAGING SOFTWARE | February 5, 2001 |
| K002631 | eemagine medical imaging solutions | ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG | October 23, 2000 |
| K993708 | biomagnetic technologies | BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG | December 3, 1999 |