| 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 | 2023-05-12MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of:
(1) MR Diffusion-weighted imaging (DWI)
(2) MR FLAIR images.
The device is intended to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians in the imaging assessment workflow:
• computation of the map relative to the water diffusion, i.e., ADC map;
• extraction and communication of metrics derived from the above map, i.e., hypointense area on ADC, and FLAIR series as well as ratios with contralateral information on FLAIR images.
The results of MR DWI/FLAIR Measurement V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care.
MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms. |
| 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 |