icobrain ct

GUDID B621ICOBRAINCT6X4Y0

icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images. icobrain mr consists of two distinct image processing pipelines: icobrain mr cross and icobrain mr long. icobrain mr cross is intended to provide volumes from images acquired at a single timepoint icobrain mr long is intended to provide changes in volumes between two images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints The results of icobrain mr cross cannot be compared with the results of icobrain mr long.

icometrix NV

Radiology DICOM image processing application software

• Primary Device ID: B621ICOBRAINCT6X4Y0
• NIH Device Record Key: d8d30fae-2e66-4d39-a118-57afb5f40144
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: icobrain ct
• Version Model Number: 6.4
• Company DUNS: 400793486
• Company Name: icometrix NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	B621ICOBRAINCT6X4Y0 [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: 2024-10-21
• Device Publish Date: 2024-10-11

Devices Manufactured by icometrix NV

• B621ICOBRAINARIA1X1Y0 - icobrain aria: 2025-02-26 icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading ai
• B621ICOBRAINCT6X4Y0 - icobrain ct: 2024-10-21icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images. icobrain mr consists of two distinct image processing pipelines: icobrain mr cross and icobrain mr long. icobrain mr cross is intended to provide volumes from images acquired at a single timepoint icobrain mr long is intended to provide changes in volumes between two images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints The results of icobrain mr cross cannot be compared with the results of icobrain mr long.
• B621ICOBRAINCT6X4Y0 - icobrain ct: 2024-10-21 icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from
• B621ICOBRAINMR5X16Y0 - icobrain mr: 2024-08-14 icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from
• B621ICOMPANION2X2Y0 - icompanion: 2024-06-17
• B621ICOBRAINMR5X15Y0 - icobrain mr: 2024-06-06 icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from
• B621ICOMPANION2X1Y0 - icompanion: 2024-02-16
• B621ICOBRAINMR5X14Y0 - icobrain mr: 2023-12-18 icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from
• B621ICOMPANION103 - icompanion: 2023-10-02