FDA.reportPublic FDA data

icobrain mr

Primary DI
B621ICOBRAINMR5X14Y0
Brand
icobrain mr
Company
icometrix NV
Model
5.14
Device description
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 timepointicobrain 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 timepointsThe results of icobrain mr cross cannot be compared with the results of icobrain mr long.
Published
2023-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B621ICOBRAINMR5X14Y0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
400793486
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B621ICOBRAINCTP1X7Y0icobrain ctp1.72026-10-22
B621ICOBRAINARIA1X2Y0icobrain aria1.22025-10-24
B621ICOBRAINMR5X17Y0icobrain mr5.172025-09-19
B621ICOBRAINARIA1X1Y0icobrain aria1.12025-02-18
B621ICOBRAINCT6X4Y0icobrain ct6.42024-10-11
B621ICOBRAINMR5X16Y0icobrain mr5.162024-08-06
B621ICOMPANION2X2Y0icompanion2.22024-06-07
B621ICOBRAINMR5X15Y0icobrain mr5.152024-05-29
B621ICOMPANION2X1Y0icompanion2.12024-02-08
B621ICOBRAIN60icobrain62022-06-24
B621ICOBRAINCTP10icobrain ctp12022-06-24
B621ICOBRAIN50icobrain52020-02-17
B621ICOBRAIN40icobrain4.02019-04-08
B621ICOBRAIN20icobrain22018-01-29
B621ICOBRAIN30icobrain32018-03-19
B621ICOMPANION103icompanion12023-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
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