Eu Mdr Eu Md Class 2a On The Market 🇫🇷 France

MR Diffusion Perfusion Mismatch V1.0

Olea Medical S.A.S. · 🇫🇷 France
Devices (same UDI-DI)
1
Certificates
0
Countries
17
Notified Bodies
0

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Basic Information

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.

Additional Description

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.

CND Nomenclature Codes

Code Description
Z11050182 MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇨🇾 Cyprus 🇩🇪 Germany 🇪🇪 Estonia 🇪🇸 Spain 🇫🇷 France 🇭🇷 Croatia 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇺 Luxembourg 🇲🇹 Malta 🇳🇱 Netherlands 🇵🇱 Poland 🇸🇮 Slovenia

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