MR Diffusion Perfusion Mismatch V1.0

Primary DI

+EOLEMRDPMV1P00

Basic UDI-DI Code

++EOLEMRDPM96

Reference

AP-NV-DP-MR

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Olea Medical S.A.S.

MR Diffusion Perfusion Mismatch V1.0 is an image processing software allowing • computation of parametric maps from (1) MR Diffusion Weighted Images (DWI) and (2) MR Perfusion Weighted Images (PWI) • and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided. MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical integration environments, responsible for transferring, storing, converting formats, notifying of detected image variations and display of DICOM imaging data. The results of MR Diffusion Perfusion Mismatch 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).