Oasis

Primary DI

00857198006013

Basic UDI-DI Code

B-00857198006013

Reference

3.0.1

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Segami Corporation

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.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).