510(k) · Cleared
ClearedElectroencephalograph Software Eemagine Eeg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eemagine Medical Imaging Solutions GmbH · OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Cleared on Oct 23, 2000 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 23, 2000
- Review
- 61 days
- Class
- Class II
- Product code
- OLX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK002631 Electroencephalograph Software Eemagine EegEemagine Medical Imaging Solutions GmbH · 2000
- Descendant · cites it directly · 4 of its ownK092844 GeosourceElectrical Geodesics, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK172858 PreOpEpilog · 2018
- Descendant · 3 generations on · 0 of its ownK252565 PreOp v3Clouds of Care · 2026
- Descendant · 3 generations on · 0 of its ownK250239 NeuroMatchLVIS Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK241513 SourcererBrain Electrophysiology Laboratory Company, LLC · 2024
Most influential descendants
Showing 5 of 5 · See all- K092844GeosourceElectrical Geodesics, Inc. · 2010 · cites it directly4descendants
- K172858PreOpEpilog · 2018 · 2 generations on2descendants
- K252565PreOp v3Clouds of Care · 2026 · 3 generations on0descendants
- K250239NeuroMatchLVIS Corporation · 2025 · 3 generations on0descendants
- K241513SourcererBrain Electrophysiology Laboratory Company, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002631 | Electroencephalograph Software Eemagine Eeg | Eemagine Medical Imaging Solutions GmbH | 2000 | — |
| +1 | K092844 | Geosource | Electrical Geodesics, Inc. | 2010 | — |
| +2 | K172858 | PreOp | Epilog | 2018 | — |
| +3 | K252565 | PreOp v3 | Clouds of Care | 2026 | — |
| +3 | K250239 | NeuroMatch | LVIS Corporation | 2025 | — |
| +2 | K241513 | Sourcerer | Brain Electrophysiology Laboratory Company, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLX device
- #1 K260563 CN-Suite™score 13.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092844 | Geosource | 2010 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092844 (Electrical Geodesics, Inc., 2010) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OLX devicesOLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLX
462in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLX
No recall names OLX since 2007.
Adverse event reports per year · OLX
1in 2015
MAUDE reports naming product code OLX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 462 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K002631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002631: Electroencephalograph Software Eemagine Eeg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002631
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026