MR DWI/FLAIR Measurement V1.0

Primary DI

+EOLEMRDFMV1P00

Basic UDI-DI Code

++EOLEMRDFM88

Reference

AP-NV-DF-MR

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Olea Medical S.A.S.

MR DWI/FLAIR Measurement V1.0 is an Image processing application indicated for use in the analysis of: • MR Diffusion weighted images (DWI) • MR Fluid Attenuated Inversion Recovery (FLAIR) images. The device is intended to be used in the imaging assessment workflow by allowing: • Computation of the map relative to the water diffusion, i.e., ADC map • Extraction and communication of metrics derived from the above cited map, i.e., hypointense area on ADC and FLAIR series as well as ratios with contralateral information on FLAIR images. MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms, responsible for transferring, storing, converting formats, notifying of detected image variations and display of DICOM imaging data. 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.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).