FDA.reportPublic FDA data

icometrix

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30134275693013427569icometrix1N2026-01-01Kolonel Begaultlaan 1b / 12 Leuven Vlaams Brabant BE 3012

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2113251200273337K240712icobrain ariaQBS2024-11-07
2113251680724889K192962icobrain-ctpLLZ2020-02-28
2113251990953039K192130IcobrainLLZ2019-12-13
2113251620970102K181939icobrainLLZ2018-11-06
2113251201233990K180326icobrainLLZ2018-03-08
2113251525241996K161148icobrainLLZ2016-08-09
2113251254018075
2113251634165915

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ82020-02-28
QBS12024-11-07

PMN#

GUDID#

icobrain aria - icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis). Patient management decisions should not be made solely on the basis of analysis by icobrain aria

icometrix NV

2025-10-24

icobrain mr - 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.

icometrix NV

2025-09-19

icobrain aria - icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis). Patient management decisions should not be made solely on the basis of analysis by icobrain aria

icometrix NV

2025-02-18

icobrain ct - 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.

icometrix NV

2024-10-11

icobrain mr - 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.

icometrix NV

2024-08-06

icobrain mr - 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.

icometrix NV

2024-05-29

icobrain mr - 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.

icometrix NV

2023-12-08