AP-NV-DP-MR

Organization name

Olea Medical S.A.S.

SRN

FR-MF-000002403

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 17 countries total.

Trade name

not provided

UDI-DI code

+EOLEMRDPMV1P00

Basic UDI-DI

++EOLEMRDPM96

Reference / catalog number

AP-NV-DP-MR

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product 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.

Additional information URL

https://www.olea-medical.com/en/customer/connexion/

Clinical sizes

No clinical sizes registered for this device.

• Z11050182MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES

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