FDA.reportPublic FDA data

TRIUX™ neo

Primary DI
06430056480411
Brand
TRIUX™ neo
Company
Megin Oy
Model
NM27000N
Device 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.
Published
2025-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph
OLYMagnetoencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLXSource Localization Software For Electroencephalograph Or MagnetoencephalographNeurology2
OLYMagnetoencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233985000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233985000TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY2024-05-15OLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430056480411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430056480411064300564804116430056480411

GMDN Terms#

Term, Definition table
TermDefinition
Magnetoencephalography system, superconductingAn 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
538025107
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430056480428Finger response padNM20928X2025-04-11
06430056480008Elekta Neuromag® TRIUXNM23900N2016-09-23
06430056480381TRIUX™ neo couchNM25906N 2018-04-30
06430056480039MaxFilter™ 2.2SW24051N2025-05-23
06430056480404MEGreview™SW26241N2025-05-23
06430056480343HPI coil set (VectorView)NM20555XNM20555N2016-09-23
0643005648029960-channel cap (S)NM20885N2016-09-23
0643005648030560-channel cap (M)NM20884N2016-09-23
0643005648031260-channel cap (L)NM20886N2016-09-23
06430056480329124-channel cap (M)NM21302N2016-09-23
06430056480336Auditory stimulator earphones (VectorView)EL21103J2016-09-23
0643005648011432-channel EEG cap (S)NM24430NNM23905N2016-09-23
0643005648012132-channel EEG cap (M)NM24431NNM23906N2016-09-23
0643005648013832-channel EEG cap (L)NM24432NNM23907N2016-09-23
06430056480015Elekta Neuromag® TRIUXNM25000N2016-09-23
06430056480022Data analysis software 3.4SW23380N2016-09-23
06430056480046MaxFilter™ 2.2SW25613N2016-09-23
06430056480053Patient chairNM23124N2016-09-23
06430056480060Patient couch NM23125N2016-09-23
06430056480077Child insert for chairBC20899N2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056774017NeuroMatchLVIS CORPORATIONOLX2026-05-12
05430000733038Persyst ESI powered by EpilogClouds of CareOLX2026-04-20
09342451002433Compumedics CurryCOMPUMEDICS LIMITEDOLX2026-03-12
00860008953100SourcererBrain Electrophysiology Laboratory Company, LLCOLX2025-10-20
06430056480039MaxFilter™ 2.2Megin OyOLY2025-05-23
06430056480404MEGreview™Megin OyOLX2025-05-23
06430056480404MEGreview™Megin OyOLY2025-05-23
06430056480428Finger response padMegin OyOLY2025-04-11
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpOLX2023-07-24
05430000733045Persyst ESI powered by EpilogClouds of CareOLX2023-06-14
05430000733021PreOpClouds of CareOLX2022-06-22
00850033571028GeoSource 2.0 Source Estimation SoftwareMagstim, Inc.OLX2022-01-25
B956CO0275110CTF MEGCTF MEG International Services Limited PartnershipOLY2020-12-01
05430000733007PreOp Clouds of CareOLX2020-10-01
06430056480374TRIUX™ neo chairMegin OyOLY2018-04-30
06430056480381TRIUX™ neo couchMegin OyOLY2018-04-30
06430056480398TRIUX™ neoMegin OyOLY2018-04-30
06430056480367Pediatric comfort setMegin OyOLY2018-04-10
04961311926266RICOH MEGRICOH COMPANY,LTD.OLY2018-03-07
04961311926266RICOH MEGRICOH COMPANY,LTD.OLX2018-03-07
00863003000343GeoSourceELECTRICAL GEODESICS, INC.OLX2016-10-04
0643005648011432-channel EEG cap (S)Megin OyOLY2016-09-23
06430056480008Elekta Neuromag® TRIUXMegin OyOLY2016-09-23
06430056480008Elekta Neuromag® TRIUXMegin OyOLX2016-09-23
06430056480015Elekta Neuromag® TRIUXMegin OyOLY2016-09-23
06430056480015Elekta Neuromag® TRIUXMegin OyOLX2016-09-23
06430056480022Data analysis software 3.4Megin OyOLX2016-09-23
06430056480046MaxFilter™ 2.2Megin OyOLY2016-09-23
06430056480053Patient chairMegin OyOLY2016-09-23
06430056480060Patient couch Megin OyOLY2016-09-23