Automation Platform V1.5

GUDID EOLEAUTOMATIONV1P50

Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Automation Platform V1.5 stores, converts formats and displays medical device data. Automation Platform V1.5 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself. Automation Platform V1.5 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Automation Platform V1.5 reads DICOM tags and pixel data to label images. Automation Platform V1.5 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs. Automation Platform V1.5 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan. Automation Platform V1.5 is intended to be used by trained professionals. Automation Platform V1.5 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.

Olea Medical USA

Radiology PACS software

• Primary Device ID: EOLEAUTOMATIONV1P50
• NIH Device Record Key: bd061b57-c3e7-4903-a7f7-8fa19c602e53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automation Platform V1.5
• Version Model Number: 1.5
• 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	EOLEAUTOMATIONV1P50 [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: 2022-11-30
• Device Publish Date: 2022-11-22

Devices Manufactured by Olea Medical USA

• EOLECTPERFUSIONV1P00 - CT Perfusion: 2023-08-08 CT Perfusion V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software al
• EOLENEUROVASV1P00 - Olea S.I.A. Neurovascular: 2023-08-08 Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I
• EOLEMRDFMV1P00 - MR DWI/FLAIR Measurement: 2023-05-12 MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of: (1) MR Diffusion-weighted
• 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: 2022-11-30Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Automation Platform V1.5 stores, converts formats and displays medical device data. Automation Platform V1.5 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself. Automation Platform V1.5 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Automation Platform V1.5 reads DICOM tags and pixel data to label images. Automation Platform V1.5 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs. Automation Platform V1.5 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan. Automation Platform V1.5 is intended to be used by trained professionals. Automation Platform V1.5 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.
• 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
• EOLEFMRIV1P00 - FUNCTIONAL MR: 2022-09-30 Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software
• 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