FDA.reportPublic FDA data

Neuro Insight

Primary DI
EOLENEUROINSIGHTV1P00
Brand
Neuro Insight
Company
Olea Medical USA
Model
V1.0
Catalog number
AP-NI-MR or AP-NI-NP-MR or AP-NI-NS-MR
Device description
Neuro Insight V1.0 is an image processing solution. It is intended to assist appropriately trained medical professionals in their analysis workflow on neurological MRI images. Neuro Insight V1.0 is composed of two subsets, including an image processing application package (NeuroPro) and an optional user interface (Neuro Synchronizer).
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
K243681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243681000Neuro Insight V1.0Olea Medical S.A.S.2025-07-23LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EOLENEUROINSIGHTV1P00PrimaryHIBCC0

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
EOLENEUROVASIV1P00Neurovascular InsightV1.0AP-NVI-CT or AP-NVI-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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