Neurovascular Insight

Primary DI
EOLENEUROVASIV1P00
Brand
Neurovascular Insight
Company
Olea Medical USA
Model
V1.0
Catalog number
AP-NVI-CT or AP-NVI-MR
Device description
Neurovascular Insight V1.0 is an optional user interface for use on a compatible technical integration environment and designed to be used by trained professionals with medical imaging education including, but not limited to, physicians.Neurovascular Insight V1.0 is intended to:• Display and, if necessary, export neurological DICOM series and outputs provided by compatible processing docker applications, through the technical integration environment.• Allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided by the technical integration environment as inputs to the docker application to reprocess the outputs. When available, Neurovascular Insight V1.0 display can be updated with the reprocessed outputs.• If requested by an application, allow the user to confirm information before displaying associated outputs and export them.
Published
2026-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243680000Neurovascular Insight V1.0Olea Medical S.A.S.2025-08-25LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EOLENEUROVASIV1P00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Contacts#

Phone, Email table
PhoneEmail
+33442712420contact@olea-medical.com

Regulatory Flags#

DUNS number
047358761
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EOLENEUROINSIGHTV1P00Neuro InsightV1.0AP-NI-MR or AP-NI-NP-MR or AP-NI-NS-MR2026-04-13
EOLECTPERFUSIONV1P00CT PerfusionV1.02023-07-31
EOLENEUROVASV1P00Olea S.I.A. NeurovascularV1.02023-07-31
EOLEMRDFMV1P00MR DWI/FLAIR MeasurementV1.02023-05-04
EOLEMRDPMV1P00MR Diffusion Perfusion MismatchV1.02023-03-08
EOLEAUTOMATIONV1P50Automation Platform V1.51.52022-11-22
EOLEOLEASIAV1P00Olea S.I.A V1.01.02022-11-22
EOLEFMRIV1P00FUNCTIONAL MRV1.02022-09-22
EOLEBREASTSCAPEV1P00BREASTSCAPEV1.02021-09-14
EOLEAUTOMATIONV1P01Automation Platform1.02019-11-25
EOLEOLEASPHEREV2P31OLEA SPHERE2.32017-05-12
EOLEOLEASPHEREV3P01OLEA SPHERE3.02016-09-22

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Primary DI, Brand, Company table
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08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
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