Neuroreader

GUDID 05700002060419

Brainreader ApS

Image segmentation application software

• Primary Device ID: 05700002060419
• NIH Device Record Key: 6e4e0d21-58e8-452d-b171-c73888636ef5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuroreader
• Version Model Number: 2.2.9
• Company DUNS: 305279427
• Company Name: Brainreader ApS
• 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

Customer Support Contacts

• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net
• Phone: +4553524749
• Email: support@brainreader.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700002060402 [Previous]
GS1	05700002060419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140828

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2017-05-04

On-Brand Devices [Neuroreader]

• 05700002060440: 2.4
• 05700002060433: 2.3
• 05700002060419: 2.2.9
• 05700002060402: 2.2.8
• 05700002060457: 2.5
• 05700002060464: 2.6
• 05700002060471: 2.7