FDA product code OLX: Source Localization Software For Electroencephalograph Or Magnetoencephalograph
OLX is the FDA product code for source localization software for electroencephalograph or magnetoencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel. FDA has cleared 25 510(k) submissions under OLX, 5 in the last five years, from 18 different applicants. The average 510(k) review took 188 days (median 149); 144 days on average over the last three years.
Definition
Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
Classification
| Field | Value |
|---|---|
| Device name | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Device class | Class II |
| Regulation | 21 CFR 882.1400 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OLX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 110 |
| 2020 | 1 | 166 |
| 2021 | 1 | 158 |
| 2024 | 2 | 135 |
| 2025 | 1 | 116 |
| 2026 | 2 | 180 |
Compare with all 510(k) review times · Search every OLX clearance
Top OLX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Elekta Neuromag OY | 4 | 2010-10-26 |
| Biomagnetic Technologies, Inc. | 3 | 1999-12-03 |
| Eemagine Medical Imaging Solutions GmbH | 2 | 2007-07-30 |
| Neurosoft, Inc. | 2 | 2001-09-19 |
| FIND Surgical Sciences Inc. D/B/A FIND Neuro | 1 | 2026-08-16 |
13 more applicants have OLX clearances. See the full list in Caduvo.
Most recent OLX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260563 | FIND Surgical Sciences Inc. D/B/A FIND Neuro | CN-Suite | 2026-08-16 | 178 |
| K252565 | Clouds of Care | PreOp v3 | 2026-02-13 | 183 |
| K250239 | LVIS Corporation | NeuroMatch | 2025-05-23 | 116 |
| K241513 | Brain Electrophysiology Laboratory Company, LLC | Sourcerer | 2024-09-27 | 121 |
| K233985 | Megin OY | TRIUX neo (NM27000N ); MEGreview (SW26241N-B) | 2024-05-15 | 149 |
Recalls for OLX devices
openFDA lists no recalls for product code OLX.
Frequently asked questions
What is FDA product code OLX?
OLX is the FDA product code for source localization software for electroencephalograph or magnetoencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel.
What device class is OLX?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLX?
Across 25 cleared submissions the average was 188 days from receipt to decision (median 149).
Which companies have the most OLX clearances?
Elekta Neuromag OY (4); Biomagnetic Technologies, Inc. (3); Eemagine Medical Imaging Solutions GmbH (2); Neurosoft, Inc. (2); FIND Surgical Sciences Inc. D/B/A FIND Neuro (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OLX
- Run a recall and safety report across every OLX manufacturer
- Watch product code OLX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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