E.M.S. Electro Medical Systems S.A. FT-221#HF/A/008 AIR-FLOW

ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies.The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

The IRIS software is a software as a service application that is hosted on the internet which allows clinicians the ability to scan a patient's retina with a fundus camera,transmit the images up to a website and offer an opinion on the scans. It also allows users the ability to input data relative to a visual fields exam.

PORTABLE WORKSTATIONWirelessly Transfer Images Directly to PACS, Ultra-light, and Portable, Design tested to handle, water, dust, and splash resistanceThe DELWORKS FIT portable tablet workstation aims to maximize the portability and efficiency of the DELWORKS software - utilizing it anytime, anywhere.

S2188 NovoTHOR Gen 3.0 Reg

S2190 NovoTHOR Gen 3.0 XL

S2189 NovoTHOR Gen 3.0 Reg PRX

S2186 NovoTHOR Gen 3.0 XL PRX

Brainlab Elements Guide XT is a software application designed to support neurosurgeons and neurologists in Deep Brain Stimulation (DBS) treatments. It enables stimulation field simulation and visualization of the stimulation field model in the context of anatomical images. This functionality can be used to aid in lead parameter adjustment in the context of minimally invasive cranial neurological procedures.Brainlab Elements Guide XT is used in combination with other applications that provide functionality for image fusion, segmentation, etc.Guide XT is compatible with selected Boston Scientific leads and implantable pulse Generators but does not directly interact with the surgeon.

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. Medis Suite MRCT is intended to support the following visualization functionalities:- cine loop and 2D review- double oblique review- 3D review by means of MIP and volume rendering- 3D reformatting - performing caliper measurements Medis Suite MRCT is also intended to support the following analyses:- cardiac function quantification- MR velocity-encoded flow quantification- anatomy and tissue segmentation - signal intensity analysis for the myocardium and infarct sizing- MR parametric maps (such as T1, T2, T2* relaxation)Medis 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.

ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies.The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

The IRIS software is a software as a service application that is hosted on the internet which allows clinicians the ability to scan a patient's retina with a fundus camera,transmit the images up to a website and offer an opinion on the scans. It also allows users the ability to input data relative to a visual fields exam.

PORTABLE WORKSTATIONWirelessly Transfer Images Directly to PACS, Ultra-light, and Portable, Design tested to handle, water, dust, and splash resistanceThe DELWORKS FIT portable tablet workstation aims to maximize the portability and efficiency of the DELWORKS software - utilizing it anytime, anywhere.