Berlin Heart GmbH D03I-111 EXCOR®

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.

Critical Care Suite 2.1, Designated Medical Device

EASYMAG SOFTWARE V2.1 : virtual reference

SUTURE ANCHOR, PEEK SUTURETAK 3 X 12.2MM

DBL LOADED 5.5MM PEEK SWVLK

SUTR ANCH,BIO-COMP S-TAK

Set Includes the following: 242-100-008 : 2.5 mm Grasper 242-100-004 : 2.1 mm Left Blunt Nose Grasper 242-100-005 : 2.1 mm Down Blunt Nose Grasper 242-100-006 : 2.1 mm Up Blunt Nose Grasper 242-100-002 :2.1 mm Straight Blunt Nose Grasper 242-100-012 : 2.7 mm Straight Blunt Nose 242-100-007 : 2.5 mm Championª Scissors 242-100-013 : 2.7 mm Up Blunt Nose

QuadraTENS dual-channel system allows you to relax two sets of muscles simultaneously. It’s ability to target both cranial nerves and large muscle groups is what separates the QuadraTENS from all other TENs systems on the market.

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.

Critical Care Suite 2.1, Designated Medical Device

EASYMAG SOFTWARE V2.1 : virtual reference