| EOLECTPERFUSIONV1P00 - CT Perfusion | 2023-08-08CT Perfusion V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from CT Perfusion data and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided.
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 by extraction and communication of metrics from CT Perfusion dataset.
The results of CT Perfusion 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.
CT Perfusion V1.0 can be integrated and deployed through technical platforms. |
| 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 | 2022-11-30 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 |