| 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 | 2023-08-08Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians.
Olea S.I.A. Neurovascular V1.0 is intended to:
• display MR and CT series and outputs provided by compatible docker applications processing, through the technical integration platform,
• allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs.
The information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment. It is not intended to be used in lieu of the standard care imaging.
Trained professionals are responsible for viewing the full set of native images per the standard of care. |
| 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 | 2022-11-30 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 |