510(k) · Cleared
ClearedTRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megin OY · OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Cleared on May 15, 2024 as substantially equivalent to K091393 (Elekta Neuromag OY, 2010) after a 149-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it.
- Decided
- May 15, 2024
- Review
- 149 days
- Class
- Class II
- Product code
- OLX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K901215 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK901215 700 Series BiomagnetometerBiomagnetic Technologies, Inc. · 1990
- 6 generations backK962764 Neuromag-122Philips Medical Systems (Cleveland), Inc. · 1996
- 5 generations backK971329 CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)Ctf Systems, Inc. · 1997
- 4 generations backK030737 Omega Whole-Cortex MFG System, Models Omega 151, Omega 275Ctf Systems (2001), Inc. · 2003
- 3 generations backK041264 Elekta OYElekta Neuromag OY · 2004
- 2 generations backK050035 Elekta Neuromag with Maxwell FilterElekta Neuromag OY · 2005
- 1 generation backK091393 Elekta Neuromag with MaxfilterElekta Neuromag OY · 2010
- This deviceK233985 TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY · 2024
- Descendant · cites it directly · 0 of its ownK260563 CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND Neuro · 2026
Most influential descendants
Showing 1 of 1 · See all- K260563CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND Neuro · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901215 | 700 Series Biomagnetometer | Biomagnetic Technologies, Inc. | 1990 | — |
| −6 | K962764 | Neuromag-122 | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −5 | K971329 | CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem) | Ctf Systems, Inc. | 1997 | — |
| −4 | K030737 | Omega Whole-Cortex MFG System, Models Omega 151, Omega 275 | Ctf Systems (2001), Inc. | 2003 | — |
| −3 | K041264 | Elekta OY | Elekta Neuromag OY | 2004 | — |
| −2 | K050035 | Elekta Neuromag with Maxwell Filter | Elekta Neuromag OY | 2005 | — |
| −1 | K091393 | Elekta Neuromag with Maxfilter | Elekta Neuromag OY | 2010 | — |
| 0 (this device) | K233985 | TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY | 2024 | — |
| +1 | K260563 | CN-Suite™ | FIND Surgical Sciences Inc. D/B/A FIND Neuro | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (1)
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 |
|---|---|---|---|
| * | K091393 | Elekta Neuromag with MaxfilterSummary page 5…Predicate Device Name / Manufacturer Product Primary Codes Predicate K091393 Elekta Neuromag with MaxFilter OLX, OLY … | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260563 | CN-Suite™ | 2026 | 0 |
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 34 years and passes through 6 companies; a new generation was cleared every 5.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K260563 (FIND Surgical Sciences Inc. D/B/A FIND Neuro, 2026) has gone furthest, with 0 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. 2024, 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?
The TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely…
Read the full statement (192 words)
The TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and,
optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the
brain. These signals are recorded by a computerized data acquisition system, displayed, and may
then be interpreted by trained physicians to help localize these active areas. The locations may then
be correlated with anatomical information of the brain.
MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortices
in the brain when used in conjunction with evoked response stimulators. MEG is also used to non-
invasively locate regions of epileptic activity within the brain. The localization information provided by
MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.
TRIUX™ neo may be used for patients of all ages as appropriate for magnetoencephalography.
MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In
addition, MEGreview™ may be used for localization of eloquent cortex, such as visual, auditory,
somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with
other imaging modalities can contribute to presurgical evaluation.
MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.
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/K233985 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233985: TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233985
Report an extraction error
Are you the manufacturer?
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