FUNCTIONAL MR

GUDID EOLEFMRIV1P00

Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers. Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis. Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images.

Olea Medical USA

Radiology PACS software
Primary Device IDEOLEFMRIV1P00
NIH Device Record Key34fb0767-5527-404b-bc3e-24b768b9462b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFUNCTIONAL MR
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEOLEFMRIV1P00 [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 Date2022-09-30
Device Publish Date2022-09-22

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EOLEFMRIV1P00 - FUNCTIONAL MR2022-09-30Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers. Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis. Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images.
EOLEFMRIV1P00 - FUNCTIONAL MR2022-09-30 Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software
EOLEBREASTSCAPEV1P00 - BREASTSCAPE2021-09-22 breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software pack

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