MR Diffusion Perfusion Mismatch

GUDID EOLEMRDPMV1P00

MR Diffusion Perfusion Mismatch V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from (1) MR Diffusion-weighted imaging (DWI) and (2) MR Perfusion-weighted imaging (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. The device is intended to assist trained radiologists and surgeons in the imaging assessment workflow by extraction and communication of metrics from MR Diffusion-weighted imaging (DWI) and MR Perfusion-weighted imaging (PWI). 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. MR Diffusion Perfusion Mismatch V1.0 can be integrated and deployed through technical platforms.

Olea Medical USA

Radiology PACS software
Primary Device IDEOLEMRDPMV1P00
NIH Device Record Key1900fd93-bcfa-4547-87de-07074cbe7ce1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR Diffusion Perfusion Mismatch
Version Model NumberV1.0
Company DUNS047358761
Company NameOlea Medical USA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com
Phone+33442712420
Emailcontact@olea-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEOLEMRDPMV1P00 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-16
Device Publish Date2023-03-08

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