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FDA-cleared K240712

icobrain aria

icometrix NV

Authorized purpose: Provides concurrent CADe/CADx aid for trained radiologists detecting, assessing, and characterizing ARIA-E and ARIA-H on brain MR images.

Modality
MRI
Anatomy
Brain
Decision
2024-11-07
FDA-cleared K192962

icobrain-ctp

Icometrix NV

Authorized purpose: Analyzes and communicates dynamic CT-perfusion datasets.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-02-28
FDA-cleared K192130

Icobrain

Icometrix NV

icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT 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 or NCCT images. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long.

Modality
MRI
Anatomy
Brain
Decision
2019-12-13
FDA-cleared K181939

icobrain

icometrix NV

Authorized purpose: icobrain segments and quantifies brain structures and lesions from MRI or noncontrast CT using cross-sectional and longitudinal workflows with acquisition-consistency limits.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2018-11-06