MEGreview™

GUDID 06430056480404

MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be used for localization of eloquent cortex, such as visual, auditory, somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with other imaging modalities can contribute to presurgical evaluation. MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.

Megin Oy

Magnetoencephalography system, superconducting

• Primary Device ID: 06430056480404
• NIH Device Record Key: b4069f99-dc06-48e3-8f7d-d8772581a489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEGreview™
• Version Model Number: SW26241N
• Company DUNS: 538025107
• Company Name: Megin 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430056480404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233985

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: 1
• Public Version Date: 2025-06-02
• Device Publish Date: 2025-05-23

Devices Manufactured by Megin Oy

• 06430056480039 - MaxFilter™ 2.2: 2025-06-02 MaxFilter™ is used with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUXTM neo in suppressing magnetic interference and in
• 06430056480404 - MEGreview™: 2025-06-02MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be used for localization of eloquent cortex, such as visual, auditory, somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with other imaging modalities can contribute to presurgical evaluation. MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.
• 06430056480404 - MEGreview™: 2025-06-02 MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be us
• 06430056480411 - TRIUX™ neo: 2025-06-02 TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electro-encephalographic (EEG)
• 06430056480428 - Finger response pad: 2025-04-21 A finger response pad for detecting patient responses.