MR DWI/FLAIR Measurement

Primary DI

EOLEMRDFMV1P00

Brand

MR DWI/FLAIR Measurement

Company

Olea Medical USA

Model

V1.0

Device description

MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of: (1) MR Diffusion-weighted imaging (DWI) (2) MR FLAIR images. The device is intended to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians in the imaging assessment workflow: • computation of the map relative to the water diffusion, i.e., ADC map; • extraction and communication of metrics derived from the above map, i.e., hypointense area on ADC, and FLAIR series as well as ratios with contralateral information on FLAIR images. The results of MR DWI/FLAIR Measurement V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care. MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms.

Published

2023-05-04

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

OTC

false

Sterile

false

Single use

false