Regulatory
Instructions for Use are available in English, Spanish, French, Portuguese (Brazil), German, Danish, Greek, Croatian, Italian, Dutch, Norwegian, Polish, Portuguese, Romanian, Swedish, Slovenian, and Turkish.
To request a non-English IFU, please contact support@segamicorp.com.
Intended Use
Oasis is indicated for processing and review of diagnostic medical images produced by DICOM based multi-modality sources; in other words, it provides the physicians with a tool to get, format, store and display diagnostic image data in all traditional manners; to add three-dimensional and multi-planar renderings to the displays; to fuse multimodality images and to display certain kinetic attributes of the imaged organs and systems.
Analysis in Oasis is NOT intended to be used as a replacement for visual interpretation nor as a diagnostic tool without other clinical and laboratory information.
Oasis is not used to treat the patient, to monitor vital signs or to give a direct diagnosis of disease.
Indications for use
Oasis software is used by trained medical professionals for processing and review of diagnostic images produced by DICOM based multi-modality sources as a tool which aids in the diagnosis, monitoring, and prediction of disease.
Neurology
Neurology evaluations for various disease states, including but not limited to: Alzheimer’s, Parkinson’s disease, epilepsy, pre- and post-therapy studies, normal pressure hydrocephalus, and brain death. Oasis is used to reconstruct tomographic data, filter, display, and quantify data for evaluation.
Cardiovascular
Cardiovascular evaluation for coronary artery ischemia. Oasis is used to reconstruct tomographic data and display these volumes to determine the extent of coronary artery disease. Cardiovascular evaluation for ejection fraction/wall motion. Oasis is used to display, filter, and post-process images to calculate ejection fraction.