TRIUX™ neo

GUDID 06430056480411

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.

Megin Oy

Magnetoencephalography system, superconducting

• Primary Device ID: 06430056480411
• NIH Device Record Key: 8e5d57ba-dd29-4294-b18d-a0abc791d407
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIUX™ neo
• Version Model Number: NM27000N
• Company DUNS: 538025107
• Company Name: Megin Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430056480411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233985

FDA Product Code

• OLY: Magnetoencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-02
• Device Publish Date: 2025-05-23

Devices Manufactured by Megin Oy

• 06430056480039 - MaxFilter™ 2.2: 2025-06-02 MaxFilter™ is used with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUXTM neo in suppressing magnetic interference and in
• 06430056480404 - MEGreview™: 2025-06-02 MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be us
• 06430056480411 - TRIUX™ neo: 2025-06-02TRIUX™ 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.
• 06430056480411 - TRIUX™ neo: 2025-06-02 TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electro-encephalographic (EEG)
• 06430056480428 - Finger response pad: 2025-04-21 A finger response pad for detecting patient responses.