510(k) · Cleared
ClearedPreOp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epilog · OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Cleared on Jan 8, 2018 as substantially equivalent to K092844 (Electrical Geodesics, Inc., 2010) and 1 other predicate after a 110-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Jan 8, 2018
- Review
- 110 days
- Class
- Class II
- Product code
- OLX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002631 (2000). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002631 Electroencephalograph Software Eemagine EegEemagine Medical Imaging Solutions GmbH · 2000
- 1 generation backK092844 GeosourceElectrical Geodesics, Inc. · 2010
- This deviceK172858 PreOpEpilog · 2018
- Descendant · cites it directly · 0 of its ownK252565 PreOp v3Clouds of Care · 2026
- Descendant · cites it directly · 0 of its ownK250239 NeuroMatchLVIS Corporation · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002631 | Electroencephalograph Software Eemagine Eeg | Eemagine Medical Imaging Solutions GmbH | 2000 | — |
| −1 | K092844 | Geosource | Electrical Geodesics, Inc. | 2010 | — |
| 0 (this device) | K172858 | PreOp | Epilog | 2018 | — |
| +1 | K252565 | PreOp v3 | Clouds of Care | 2026 | — |
| +1 | K250239 | NeuroMatch | LVIS Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092844 | GeosourceSummary page 4…21 CFR 882.1400 Product Code: OLX Class: II Classification Panel: Neurology 3. PREDICATE DEVICES Primary Predicate Device: K092844, GeoSource Intended use: GeoSource is intended for use by a trained/qualified EEG… | 2010 |
| * | K001781 | Curry Multimodal Neuroimaging SoftwareSummary page 4…idealized head model and an idealized MRI image. The primary predicate device has not been subject to a design-related recall. Secondary Predicate Device: K001781, Curry Multimodal Imaging Software Intended use: No 510(k) Summary Posted; not publicly available. The secondary p… | 2001 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252565 (Clouds of Care, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K092844.
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. 2018, this device’s year, is highlighted.
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 | — |
What is it indicated for?
PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172858: PreOp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172858
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026