TRIUX™ neo

GUDID 06430056480398

The TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by

Elekta Oy

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• Primary Device ID: 06430056480398
• NIH Device Record Key: 9b0deb62-a7d5-46c1-a42c-1f178358df6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIUX™ neo
• Version Model Number: NM26000N
• Company DUNS: 538025107
• Company Name: Elekta 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430056480398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091393

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-30

Devices Manufactured by Elekta Oy

• 06430056480008 - Elekta Neuromag® TRIUX: 2018-07-06 The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalo
• 06430056480015 - Elekta Neuromag® TRIUX: 2018-07-06 The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalo
• 06430056480022 - Data analysis software 3.4: 2018-07-06 A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®.
• 06430056480046 - Elekta Neuromag ® Data Analysis Software MaxFilter: 2018-07-06
• 06430056480053 - Patient chair: 2018-07-06 Adjustable patient chair with accessories for comfortable seated measurement position.
• 06430056480060 - Patient couch: 2018-07-06 Patient couch for the supine measurement position.
• 06430056480077 - Child insert for chair: 2018-07-06 A booster seat and neck collar for pediatric patients.
• 06430056480084 - Auditory stimulator (earphones): 2018-07-06 A binaural auditory stimulator for eliciting auditory evoked fields.