DEVICE: TRIUX™ neo (06430056480411)
Device Identifier (DI) Information
TRIUX™ neo
NM27000N
In Commercial Distribution
Megin Oy
NM27000N
In Commercial Distribution
Megin Oy
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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46495 | Magnetoencephalography system, superconducting |
An assembly of devices intended to be used to noninvasively detect, measure, and display bio-magnetic signals produced by electrically-active brain tissue, and to provide diagnostic information about the location of the active tissue responsible for cognitive brain functions relative to the surrounding brain anatomy [magnetoencephalography (MEG)]. It consists of a movable gantry, patient support apparatus, dewar [vessel containing liquid helium (He)], dedicated software, and a superconducting quantum interference device (SQUID) sensor array that measures the magnetic fields created by neuronal electrical currents. It is typically sited within a magnetically-shielded room (MSR).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OLY | Magnetoencephalograph |
OLX | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K233985 | 000 |
Sterilization
Storage and Handling
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Clinically Relevant Size
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Device Record Status
8e5d57ba-dd29-4294-b18d-a0abc791d407
June 02, 2025
1
May 23, 2025
June 02, 2025
1
May 23, 2025
Alternative and Additional Identifiers Additional Identifiers
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Unit of Use DI
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined