510(k) K241513
- Device
- Sourcerer
- Applicant
- Brain Electrophysiology Laboratory Company, LLC
- 510(k) number
- K241513
- Product code
- OLX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-27
- Date received
- 2024-05-29
- Regulation
- 882.1400
- Classification name
- Source Localization Software For Electroencephalograph Or Magnetoencephalograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Phan Luu
- Address
- 1776 Millrace Dr. Suite 304 Eugene OR US 97403 97403
FDA Registration Numbers#
- 9613619
- 1650946
- 3023707151
- 3017666517
- 3015929663
- 2031720
- 3014291198
- 9612330
- 3010749841
- 3033708293
- 3014137562
- 9680891
Source Documents#
Other 510(k) Records For Product Code OLX#
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|---|---|---|---|
| K260563 | CN-Suite™ | FIND Surgical Sciences Inc. D/B/A FIND Neuro | 2026-08-16 |
| K252565 | PreOp v3 | Clouds of Care | 2026-02-13 |
| K250239 | NeuroMatch | LVIS Corporation | 2025-05-23 |
| K233985 | TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY | 2024-05-15 |
| K210199 | RICOH MEG | Ricoh Company, Ltd. | 2021-07-02 |
| K201910 | EZTrack | Neurologic, LLC | 2020-12-22 |
| K172858 | PreOp | Epilog | 2018-01-08 |
| K092844 | GEOSOURCE | Electrical Geodesics, Inc. | 2010-12-21 |
| K100126 | STELLATE GRIDVIEW | Excel-Tech Ltd. (Xltek) | 2010-12-03 |
| K091393 | ELEKTA NEUROMAG WITH MAXFILTER | Elekta Neuromag OY | 2010-10-26 |
| K081430 | ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING | Elekta Neuromag OY | 2008-07-28 |
| K070358 | MAXINSIGHT | Eemagine Medical Imaging Solutions GmbH | 2007-07-30 |
| K050035 | ELEKTA NEUROMAG WITH MAXWELL FILTER | Elekta Neuromag OY | 2005-01-25 |
| K041264 | ELEKTA OY | Elekta Neuromag OY | 2004-08-10 |
| K040051 | MEGVISION, MODEL EQ1000C SERIES | Eagle Technology, Inc. | 2004-03-24 |