Olea S.I.A V1.0

GUDID EOLEOLEASIAV1P00

Olea S.I.A V1.0 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Olea S.I.A V1.0 stores, converts formats and displays medical device data. Olea S.I.A V1.0 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. Olea S.I.A V1.0 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Olea S.I.A V1.0 reads DICOM tags and pixel data to label images. Olea S.I.A V1.0 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs. Olea S.I.A V1.0 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan. Olea S.I.A V1.0 is intended to be used by trained professionals. Olea S.I.A V1.0 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: EOLEOLEASIAV1P00
• NIH Device Record Key: 2e947a50-b7d0-43b4-b64a-8949e605fd6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olea S.I.A V1.0
• 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	EOLEOLEASIAV1P00 [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: 2022-11-30 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: 2022-11-30Olea S.I.A V1.0 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Olea S.I.A V1.0 stores, converts formats and displays medical device data. Olea S.I.A V1.0 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. Olea S.I.A V1.0 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Olea S.I.A V1.0 reads DICOM tags and pixel data to label images. Olea S.I.A V1.0 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs. Olea S.I.A V1.0 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan. Olea S.I.A V1.0 is intended to be used by trained professionals. Olea S.I.A V1.0 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.
• 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