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510(k) Data Aggregation
K Number
K233985Device Name
TRIUX neo (NM27000N ); MEGreview (SW26241N-B)
Manufacturer
Megin Oy
Date Cleared
2024-05-15
(149 days)
Product Code
OLX, OLY
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
Megin Oy
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 coniunction with evoked response stimulators. MEG is also used to noninvasively 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.
Device Description
TRIUX™ neo NM27000N (TRIUX™ neo below) is a magnetoencephalographic (MEG) device, designed to non-invasively detect and display biomagnetic signals produced by electrically active nerve tissue in the brain. This system enables diagnostic capabilities by providing information about the location of active nerve tissues relative to brain anatomy. It measures both MEG and electroencephalographic (EEG) signals, which are then recorded, displayed, and interpreted by trained clinicians to aid in neurosurgical planning and locating regions of epileptic activity.
TRIUX™ neo employs 306 SQUID (Superconducting Quantum Interference Device) detectors to measure magnetic signals with minimal distortion, allowing for localization of brain activity. The detectors are housed in a cryogenic Dewar vessel, along with an internal helium recycler to maintain optimal operating conditions.
The TRIUX™ neo svstem features a probe unit with a modular structure, a patient-support system with a couch and chair for various positioning needs, and an electronics setup housed outside the magnetically shielded room. The software component, MEGflow™ facilitates data acquisition, preprocessing, and analysis, and includes functionalities for clinical epilepsy workflows, MRI integration, and visualization tools.
MEGreview™ is a software for off-line visualization, and localization of brain activity measured with magnetoencephalography (MEG) and, optionally, visualization of brain activity measured with scalp electroencephalography (EEG). MEGreview™ provides workflows for epilepsy focus localization and functional mapping including signal processing, source localization, integration with anatomical MRI and visualization of the results overlayed on anatomical information, as well as reporting and exporting the results.
MEGreview™ is intended to be used with TRIUX™ neo or equivalent MEG devices.
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