icobrain

GUDID B621ICOBRAIN50

icometrix NV

Radiology DICOM image processing application software

• Primary Device ID: B621ICOBRAIN50
• NIH Device Record Key: 08e43f02-3e1b-4ee0-a1ca-71953f20b50b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: icobrain
• Version Model Number: 5
• Company DUNS: 400793486
• Company Name: icometrix NV
• 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: 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
HIBCC	B621ICOBRAIN50 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2020-02-25
• Device Publish Date: 2020-02-17

On-Brand Devices [icobrain]

• B621ICOBRAIN30: icobrain is software intended for automatic labeling, visualization and volumetric quantificatio
• B621ICOBRAIN20: icobrain is software intended for automatic labeling, visualization and volumetric quantificatio
• B621ICOBRAIN40: 4.0
• B621ICOBRAIN50: 5
• B621ICOBRAIN60: 6