Elekta Neuromag ® Data Analysis Software MaxFilter

GUDID 06430056480046

Elekta Oy

Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph

• Primary Device ID: 06430056480046
• NIH Device Record Key: 61a6c685-895b-4052-a3f6-47f2e0aacdaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elekta Neuromag ® Data Analysis Software MaxFilter
• Version Model Number: SW25613N
• 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: true
• Serial Number: false
• 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	06430056480046 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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
• 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.