Submission Details
| 510(k) Number | K241513 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Sourcerer
Sep 2024
Decision
121d
Days
Class 2
Risk
About This 510(k) Submission
K241513 is an FDA 510(k) clearance for the Sourcerer, 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 review panel. Regulated under 21 CFR 882.1400.
Device Classification
| 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 |
Manufacturer
Similar Devices — OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
All 23
K252565 · Clouds of Care
· Feb 2026
K250239 · LVIS Corporation
· May 2025
K233985 · Megin OY
· May 2024
K210199 · Ricoh Company, Ltd.
· Jul 2021
K201910 · Neurologic, LLC
· Dec 2020
K172858 · Epilog
· Jan 2018