Identity
- Trade Name
- TRIUX™ neo FDA UDI
- Generic Name
- Magnetoencephalography system, superconducting FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- NM27000N FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430056480411 FDA UDI
- 510(k) Number
- K233985 FDA UDI
- FDA Product Code
- OLY FDA UDIOLX FDA UDI
- GMDN Term
- Magnetoencephalography system, superconducting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Magnetoencephalography system, superconducting
TRIUX™ neo by Megin Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Magnetoencephalography system, superconducting.
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Cleared under the same submission
K233985 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Megin Oy
Sources (1)
- FDA UDI 8e5d57ba-dd29-4294-b18d-a0abc791d407 34 fields · synced May 29, 2026