Oasis is a SaMD (Software as a Medical Device). It is a software product designed to operate on an office PC. The product is intended for use by qualified medical personnel for the assessment of diagnostic medical images. The Oasis product is not intended to be used as a replacement for visual interpretation, nor as a diagnostic tool without the use of other clinical and laboratory information. The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of automatic and manual processing and displaying the medical image data in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. The Oasis system displays the processed images using an integrated computer. Oasis is a software-only medical device (a SaMD). Oasis does not directly or indirectly control any medical device that has contact with the user or patient. Oasis does not automate the diagnosis of a patient in any way. Oasis does not come into contact with patients and does not contain medicinal substances or non-viable animal/human tissues.
An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a gamma camera-based imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and can be upgraded to correct programming errors or to add new system capabilities. Some must be used with specific configurations to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.