510(k) · Cleared
ClearedImage Vue Eeg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sam Technology, Inc. · OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Cleared on Aug 6, 1998 as substantially equivalent to K960071 (Radionics Software Applications, Inc., 1996) and 2 other predicates after a 181-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Aug 6, 1998
- Review
- 181 days
- Class
- Class II
- Product code
- OLX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K843598 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK843598 Brain Function Mapping Option for PathfNicolet Biomedical Instruments · 1985
- This deviceK980477 Image Vue EegSam Technology, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843598 | Brain Function Mapping Option for Pathf | Nicolet Biomedical Instruments | 1985 | — |
| 0 (this device) | K980477 | Image Vue Eeg | Sam Technology, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 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 14.0 · 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? (3)
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 |
|---|---|---|---|
| * | K960071 | ImagefusionSummary page 1…82.1400 Common/Usual Name: Electroencephalograph Software Equivalent legally marketed devices This product has features which are similar in design and function lo the K960071, Radionics Image Cormrelation Syslem; K843598, Nicolet Biomedical Instruments Brain Function Mapping Option For Pathfinder; and K… | 1996 |
| * | K843598 | Brain Function Mapping Option for PathfSummary page 1…ph Software Equivalent legally marketed devices This product has features which are similar in design and function lo the K960071, Radionics Image Cormrelation Syslem; K843598, Nicolet Biomedical Instruments Brain Function Mapping Option For Pathfinder; and K970951, The Grass Electrocncephalograph Softwa… | 1985 |
| * | K970951 | Grass Brainwave SoftwareSummary page 1…ar in design and function lo the K960071, Radionics Image Cormrelation Syslem; K843598, Nicolet Biomedical Instruments Brain Function Mapping Option For Pathfinder; and K970951, The Grass Electrocncephalograph Softwarc . Indications for Use (intended use) The software is intended for use by a qualified/t… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 ancestors has a recall.
- 2 other devices also cite its predicate K960071.
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 | — |
What is it indicated for?
The software is intended for use by a qualified/trained EEG technologist or physician on both adult and pediatric subjects for the visualization of human brain electrical activity by fusing a variety of EEG information with MRI images.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980477 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980477: Image Vue Eeg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980477
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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