visor2

GUDID B195ES600US0

visor2 component

eemagine Medical Imaging Solutions GmbH

Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system Stereotactic neuronavigation/planning system 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

• B195CS315 - waveguard: 2023-10-10 eeg cap
• B195NT1040 - tracking tools: 2022-09-29 visor2 component
• B195NT1041 - tracking tools: 2022-09-29 visor2 component
• B195NT106 - tracking tools: 2022-09-29 visor2 component
• B195NT109 - tracking tools: 2022-09-29 visor2 component
• B195NT112 - tracking tools: 2022-09-29 visor2 component
• B195NT117 - tracking tools: 2022-09-29 visor2 component
• B195NT118 - tracking tools: 2022-09-29 visor2 component