# K233985: TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)

- Pathway: 510(k) (Traditional)
- Applicant: Megin OY
- Decided: May 15, 2024 after 149 days
- Product code: OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K901215 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091393: Elekta Neuromag with Maxfilter, Elekta Neuromag OY (2010) Summary page 5.

## Most influential descendants
- K260563: CN-Suite™ (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K233985
Methodology: https://510kreport.com/methodology