Neuroreader

GUDID 05700002060464

Brainreader ApS

Image segmentation application software

• Primary Device ID: 05700002060464
• NIH Device Record Key: f34c01d9-1749-442e-a620-b03d741033a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuroreader
• Version Model Number: 2.6
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700002060457 [Previous]
GS1	05700002060464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140828

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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: 2021-07-06
• Device Publish Date: 2021-06-28

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