Automation Platform

GUDID EOLEAUTOMATIONV1P01

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.

Olea Medical USA

Radiology PACS software

• Primary Device ID: EOLEAUTOMATIONV1P01
• NIH Device Record Key: ebd8b385-43a4-43f1-b37d-a2b015d81190
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automation Platform
• Version Model Number: 1.0
• Company DUNS: 047358761
• Company Name: Olea Medical USA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EOLEAUTOMATIONV1P01 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-03
• Device Publish Date: 2019-11-25

Devices Manufactured by Olea Medical USA

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• EOLEMRDPMV1P00 - MR Diffusion Perfusion Mismatch: 2023-03-16 MR Diffusion Perfusion Mismatch V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image pro
• EOLEAUTOMATIONV1P50 - Automation Platform V1.5: 2022-11-30 Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data betwee
• EOLEOLEASIAV1P00 - Olea S.I.A V1.0: 2022-11-30 Olea S.I.A V1.0 is a medical image communications device that provides electronic transfer of medical image data between medical
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• EOLEBREASTSCAPEV1P00 - BREASTSCAPE: 2021-09-22 breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software pack