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TRIUX™ neo

Megin Oy · Model NM27000N · UDI-DI 06430056480411

OLY OLX Prescription

510(k) clearances

Adverse events

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Facilities

Description

TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electro-encephalographic (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 cortex 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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.