visor2

GUDID B195ES600US0

visor2 component

eemagine Medical Imaging Solutions GmbH

Stereotactic neuronavigation/planning system

• Primary Device ID: B195ES600US0
• NIH Device Record Key: a83e084e-d3c5-4ad7-ac18-e5a4452154d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: visor2
• Version Model Number: ES-600.US
• Company DUNS: 313152485
• Company Name: eemagine Medical Imaging Solutions GmbH
• 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: true
• 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

Customer Support Contacts

• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B195ES600US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210109

FDA Product Code

• HAW: Neurological stereotaxic Instrument

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: 2022-04-22
• Device Publish Date: 2022-04-14

Devices Manufactured by eemagine Medical Imaging Solutions GmbH

• B195EE223 - eego amplifier: 2025-10-07 physiological signal amplfier
• B195EE225 - eego amplifier: 2025-10-07 physiological signal amplfier
• B195NA247 - waveguard: 2025-09-02 eeg cap
• B195CA196 - waveguard: 2025-01-15 eeg cap
• B195CA338 - waveguard: 2025-01-15 eeg cap
• B195CA506 - waveguard: 2025-01-15 eeg cap
• B195CA546 - waveguard: 2025-01-15 eeg cap
• B195NA246 - waveguard: 2025-01-15 eeg cap