Olea S.I.A. Neurovascular

GUDID EOLENEUROVASV1P00

Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians. Olea S.I.A. Neurovascular V1.0 is intended to: • display MR and CT series and outputs provided by compatible docker applications processing, through the technical integration platform, • allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs. The information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment. It is not intended to be used in lieu of the standard care imaging. Trained professionals are responsible for viewing the full set of native images per the standard of care.

Olea Medical USA

Radiology PACS software
Primary Device IDEOLENEUROVASV1P00
NIH Device Record Keye265d750-cb4c-4a03-8002-e23bcde1a62f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOlea S.I.A. Neurovascular
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 Numbertrue
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
Phone+33442712420
Emailcontact@olea-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEOLENEUROVASV1P00 [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 Date2023-08-08
Device Publish Date2023-07-31

Devices Manufactured by Olea Medical USA

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