Elekta Neuromag® TRIUX - The Elekta Neuromag® TRIUX non-invasively - Megin Oy

Duns Number:538025107

Device Description: The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signa The Elekta Neuromag® TRIUX 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 cortex in the brain when used in conjunction with evoked response averaging devices. 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.

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More Product Details

Catalog Number

-

Brand Name

Elekta Neuromag® TRIUX

Version/Model Number

NM25000N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OLX

Product Code Name

Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Device Record Status

Public Device Record Key

83375ca1-579b-4371-ae82-b25f794531e4

Public Version Date

May 13, 2022

Public Version Number

7

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEGIN OY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 23