510(k) Report

510(k) · Cleared

Cleared

Geosource

K092844510(k) TraditionalCleared Dec 21, 2010462-day reviewClass II21 CFR 882.1400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Electrical Geodesics, Inc. · OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Cleared on Dec 21, 2010 as substantially equivalent to K002631 (Eemagine Medical Imaging Solutions GmbH, 2000) and 1 other predicate after a 462-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.

Decided
Dec 21, 2010
Review
462 days
Class
Class II
Product code
OLX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K002631 (2000). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2024: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared2025: 1 descendant clearedK002631 · Electroencephalograph Software Eemagine Eeg · Eemagine Medical Imaging Solutions GmbH · 2000200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants K002631 · Electroencephalograph Software Eemagine Eeg · Eemagine Medical Imaging Solutions GmbH · 20000
  1. Root · 1 generation backK002631 Electroencephalograph Software Eemagine EegEemagine Medical Imaging Solutions GmbH · 2000
  2. This deviceK092844 GeosourceElectrical Geodesics, Inc. · 2010
  3. Descendant · cites it directly · 2 of its ownK172858 PreOpEpilog · 2018
  4. Descendant · 2 generations on · 0 of its ownK252565 PreOp v3Clouds of Care · 2026
  5. Descendant · 2 generations on · 0 of its ownK250239 NeuroMatchLVIS Corporation · 2025
  6. Descendant · cites it directly · 0 of its ownK241513 SourcererBrain Electrophysiology Laboratory Company, LLC · 2024

Most influential descendants

Showing 4 of 4 · See all
  • K172858PreOpEpilog · 2018 · cites it directly2descendants
  • K252565PreOp v3Clouds of Care · 2026 · 2 generations on0descendants
  • K250239NeuroMatchLVIS Corporation · 2025 · 2 generations on0descendants
  • K241513SourcererBrain Electrophysiology Laboratory Company, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002631Electroencephalograph Software Eemagine EegEemagine Medical Imaging Solutions GmbH2000—
0 (this device)K092844GeosourceElectrical Geodesics, Inc.2010—
+1K172858PreOpEpilog2018—
+2K252565PreOp v3Clouds of Care2026—
+2K250239NeuroMatchLVIS Corporation2025—
+1K241513SourcererBrain Electrophysiology Laboratory Company, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202410
202510
202610
FIG. 1 — Lineage of K092844, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260563 CN-Suite™score 13.9 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K002631Electroencephalograph Software Eemagine Eeg
Summary page 1
…raph Legally marketed devices for substantial equivalence comparison: 510(k) Product Code Trade Name Manufacturer Number K002631I WQ Electroencephalograph Software eemagine Medical 882.1400 eemagine E…
Eemagine Medical Imaging Solutions GmbH2000—
*K001781Curry Multimodal Neuroimaging Software
Summary page 1
…WQ Electroencephalograph Software eemagine Medical 882.1400 eemagine EEC Imaging Solutions CmbH K001781 CWQ CURRY Multimodal Neuroimnaging Neurosoft, Inc. _______882.1400 Software D…
Neurosoft, Inc.2001—

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K172858PreOpEpilog20182
K241513SourcererBrain Electrophysiology Laboratory Company, LLC20240

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K172858 (Epilog, 2018) has gone furthest, with 2 descendants of its own.

How does its category compare?

All OLX devices

OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OLX

1in 2025

2007: 12008: 12010: 32018: 12020: 12021: 12024: 22025: 12026 (partial year): 2
2007high 3 (2010) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLX

462in 2010

2010: 462 days median
2007high 462 (2010)2026

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

2014: 12015: 1
2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code OLX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
20090—00
2010346200
20110—00
20120—00
20130—00
20140—01
20150—01
20160—00
20170—00
20181—00
20190—00
20201—00
20211—00
20220—00
20230—00
20242—00
20251—00
20262—0—

What is it indicated for?

CeoSource is intended for use by a trained/qualified EEC 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 EEC information with rendered images of an idealized head model and an idealized MRI image.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K092844: Geosource.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092844

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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