| Primary Device ID | EOLEMRDPMV1P00 |
| NIH Device Record Key | 1900fd93-bcfa-4547-87de-07074cbe7ce1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MR Diffusion Perfusion Mismatch |
| Version Model Number | V1.0 |
| Company DUNS | 047358761 |
| Company Name | Olea Medical USA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| 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 | 2023-03-16MR Diffusion Perfusion Mismatch 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 (1) MR Diffusion-weighted imaging (DWI) and (2) MR Perfusion-weighted imaging (PWI) 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 assist trained radiologists and surgeons in the imaging assessment workflow by extraction and communication of metrics from MR Diffusion-weighted imaging (DWI) and MR Perfusion-weighted imaging (PWI).
The results of MR Diffusion Perfusion Mismatch 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.
MR Diffusion Perfusion Mismatch V1.0 can be integrated and deployed through technical platforms. |
| 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 |