Automation Platform

Primary DI
EOLEAUTOMATIONV1P01
Brand
Automation Platform
Company
Olea Medical USA
Model
1.0
Device description
The Automation Platform is a software product that transfers, stores, converts formats, and displays medical device image data. It does not modify the image data or modify the display of the image data. The Automation Platform reads images and interprets DICOM tags, analyzes pixels to identify body part and sequence type in order to categorize the images.The Automation Platform is not intended to be used for active patient monitoring nor primary image interpretation.The Automation Platform allows routing DICOM-compliant image data to and from automated post processing applications, but such processing applications are not a part of the platform itself.Automation Platform allows post processing applications to provide a notification or a flag intended to inform the user.
Published
2019-11-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EOLEAUTOMATIONV1P01PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology 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. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047358761
Device count
1
Premarket exempt
true
Lot or batch
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
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
EOLEOLEASPHEREV2P31OLEA SPHERE2.32017-05-12
EOLEOLEASPHEREV3P01OLEA SPHERE3.02016-09-22

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