FDA-cleared K240712

icobrain aria

icometrix NV

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,...

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

icobrain-ctp

Icometrix NV

icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes...

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...

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

icobrain

icometrix NV

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