icobrain aria
Icometrix NV
icometrix
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013427569 | 3013427569 | icometrix | 1 | N | 2026-01-01 | Kolonel Begaultlaan 1b / 12 Leuven Vlaams Brabant BE 3012 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 211325 | 1200273337 | K240712 | icobrain aria | QBS | 2024-11-07 |
| 211325 | 1680724889 | K192962 | icobrain-ctp | LLZ | 2020-02-28 |
| 211325 | 1990953039 | K192130 | Icobrain | LLZ | 2019-12-13 |
| 211325 | 1620970102 | K181939 | icobrain | LLZ | 2018-11-06 |
| 211325 | 1201233990 | K180326 | icobrain | LLZ | 2018-03-08 |
| 211325 | 1525241996 | K161148 | icobrain | LLZ | 2016-08-09 |
| 211325 | 1254018075 | ||||
| 211325 | 1634165915 |
Product Codes Associated With Registrations#
PMN#
Icobrain-ctp
Icometrix NV
Icobrain
Icometrix NV
Icobrain
Icometrix NV
Icobrain
Icometrix
Icobrain
Icometrix
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
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.
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
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.
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.
2024-08-06
icompanion - 2.2
2024-06-07
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.
2024-05-29
icompanion - 2.1
2024-02-08
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.
2023-12-08
icobrain - icobrain is software intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images.
2018-03-19
icobrain - icobrain is software intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images.
2018-01-29
icobrain - 4.0
2019-04-08
icobrain - 5
2020-02-17
icobrain ctp - 1
2022-06-24
icobrain - 6
2022-06-24
icompanion - 1
2023-09-22