| Primary Device ID | EOLEAUTOMATIONV1P01 |
| NIH Device Record Key | ebd8b385-43a4-43f1-b37d-a2b015d81190 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Automation Platform |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | EOLEAUTOMATIONV1P01 [Primary] |
| LMD | System, Digital Image Communications, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-03 |
| Device Publish Date | 2019-11-25 |
| 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 |