Berlin Heart GmbH D03I-111 EXCOR® VAD

Medis Suite MRCT is software intended to be used for the visualization and analysis of MR and CT images of the heart and blood vessels. This includes:- double oblique review of MR Angiographic images,- 3D review by means of MIP and volume rendering,- 3D reformatting of MR Angiographic images, and- performing caliper measurements. Medis Suite MRCT is intended to support the following visualization functionalities:- cine loop and 2D review- performing caliper measurements Medis Suite MRCT is also intended to support the following analyses:- cardiac function quantification- anatomy and tissue segmentation - signal intensity analysis for the myocardium and infarct sizing- MR parametric maps (such as T1, T2, T2* relaxation)- MR velocity-encoded flow quantificationMedis Suite MRCT is also intended to be used for:- quantification of T2* results in MR images that can be used to characterize iron loading in the heart and the liver - MR velocity-encoded flow quantification of cerebral spinal fluidThese analyses 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. The results obtained are displayed on top of the images and provided in reports.The analysis results obtained with Medis Suite MRCT are intended for use by cardiologists and radiologists:- to support clinical decisions concerning the heart and vessels, and- to support the evaluation of interventions or drug therapy applied for conditions of the heart and vessels.

EASYMAG SOFTWARE V2.1 : virtual reference

ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings,veneers, bridges, pontics, provisionals, and bite splints via a 3D CAD tool. The design is basedon suitable 3D scans of the patient’s dental anatomy produced by a compatible scanner. The software generates geometricaloutput of the design for manufacturing on compatible CAM systems.ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose otherthan the design of dental restorations or bite splints, nor is it to be used for designing dental abutments.

DentalDB is a software application intended for the management of data regarding patients, cases, dental practices, dentallaboratories, and manufacturing facilities. The optional dentalshare service allows for the transfer of pertinent data to andfrom remote facilities.DentalDB is intended for use by trained professionals, such as dental technicians and dentists.