K241513 is an FDA 510(k) clearance for the Sourcerer. This device is classified as a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II - Special Controls, product code OLX).
Submitted by Brain Electrophysiology Laboratory Company, LLC (Eugene, US). The FDA issued a Cleared decision on September 27, 2024, 121 days after receiving the submission on May 29, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization.
| 510(k) Number | K241513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2024 |
| Decision Date | September 27, 2024 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLX - Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization |