Medis Suite XA is software intended to be used for performing calculations in X-ray angiographic images of the chambers of the heart and of blood vessels. These calculations are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. Medis Suite XA is also intended to be used for performing caliper measurements. The results obtained are displayed on top of the images and provided in reports.The analysis results obtained with Medis Suite XA are intended for use by cardiologists and radiologists:• to support clinical decisions concerning the heart and vessels• to support the evaluation of interventions or drug therapy applied for conditions of the heart and vessels
A software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).