Radiology AI Directory

Vendor

Olea Medical

3 FDA-cleared listings in this directory.

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FDA-cleared K230552

MR DWI/FLAIR Measurement V1.0

Olea Medical

MR DWI/FLAIR Measurement V1.0 processes brain DWI and FLAIR MRI to calculate ADC maps, segment ADC-hypointense regions, and communicate relative or normalized FLAIR measurements;...

Modality
MRI
Anatomy
Brain
Decision
2023-04-26
Quantification and segmentationNeuro MRI
FDA-cleared K223502

MR Diffusion Perfusion Mismatch V1.0

Olea Medical

MR Diffusion Perfusion Mismatch V1.0 is image-processing software for computing parametric maps from MR diffusion-weighted and perfusion-weighted imaging, extracting...

Modality
MRI
Anatomy
Brain and other anatomy represented in MR diffusion- and perfusion-weighted images
Decision
2023-01-13
MRI workflow
FDA-cleared K211431

breastscape v1.0

Olea Medical

Visualization, analysis, reporting, lesion measurement, kinetic assessment, and MR-guided breast interventional planning; when interpreted by a skilled physician, information may...

Modality
Mammography/DBT
Anatomy
Breast lesions and breast morphological landmarks including nipple, chest, and skin borders.
Decision
2021-08-02
Breast imagingQuantification and segmentation