Other products from "MEDIS MEDICAL IMAGING SYSTEMS B.V."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 B141MEDISSUITEXA2D20190 2019 Medis Suite XA is software intended to be used for performing calculations in X- 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 LLZ System, Image Processing, Radiological 2 Medis Suite XA 2D
2 B141MEDISSUITEMRCT300 3.0 Medis Suite MRCT is software intended to be used for the visualization and analy 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. LLZ System, Image Processing, Radiological 2 Medis Suite MRCT
3 B141MEDISSUITEMRCT210 2.1 Medis Suite MRCT is software intended to be used for the visualization and analy 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. LLZ System, Image Processing, Radiological 2 Medis Suite MRCT
4 B141MEDISSUITEMRCT20220 2022 Medis Suite MRCT 2022 is indicated for use in clinical settings where more repro Medis Suite MRCT 2022 is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, Medis Suite MRCT 2022 allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT 2022 can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by Medis Suite MRCT 2022 are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. LLZ System, Image Processing, Radiological 2 Medis Suite MRCT
5 B141MEDISSUITEMRCT20210 2021 Medis Suite MRCT 2021 is indicated for use in clinical settings where more repro Medis Suite MRCT 2021 is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, Medis Suite MRCT 2021 allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT 2021 can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by Medis Suite MRCT 2021 are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. LLZ System, Image Processing, Radiological 2 Medis Suite MRCT
6 B141MEDISSUITEMRCT20200 2020 Medis Suite MRCT is indicated for use in clinical settings where more reproducib Medis Suite MRCT is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, Medis Suite MRCT allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by Medis Suite MRCT 2020 are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. LLZ System, Image Processing, Radiological 2 Medis Suite MRCT
7 B141MEDISSUITEMRCT20190 2019 Medis Suite MRCT is indicated for use in clinical settings where more reproducib Medis Suite MRCT is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, Medis Suite MRCT allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by Medis Suite MRCT are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. LLZ System, Image Processing, Radiological 2 Medis Suite MRCT
8 B141MEDISSUITEMRCT20180 2018 Medis Suite MRCT is software intended to be used for the visualization and analy 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. LLZ System, Image Processing, Radiological 2 Medis Suite MRCT
9 B141QANGIOXA730 7.3 QAngio XA is image post-processing software for the viewing and quantification o QAngio XA is image post-processing software for the viewing and quantification of digital x-ray angiographic images of blood vessels and of the chambers of the heart. Semi-automatic contour detection forms the basis for the analyses. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on screen, and can be exported in various electronic formats. QAngio XA has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment.QAngio XA comprises functionalities for analyzing the blood vessels and the left ventricle, the right ventricle, stent and sub-segments, coronary aneurysms, and bifurcations. LLZ System, Image Processing, Radiological 2 QAngio XA
10 B141MEDISSUITEXA20190 2.0 QANGIO XA 3D is software intended to be used for performing calculations in X-ra QANGIO XA 3D is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. QANGIO XA 3D enables interventional cardiologists and researchers to obtain quantifications of one or more lesions in the analyzed coronary vessel segment. In particular, QANGIO XA 3D provides:• Quantitative results of coronary vessel segments based on a 3D reconstructed model;• Dimensions of the cardiovascular vessels and lesions;• Quantification of the pressure drop in coronary vessels. LLZ System, Image Processing, Radiological 2 QAngio XA 3D
11 B141MEDISSUITEXA20220 2022 Medis Suite XA 2022 is indicated for use in clinical settings where validated an Medis Suite XA 2022 is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by Medis Suite XA 2022 are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. LLZ System, Image Processing, Radiological 2 Medis Suite XA
12 B141MEDISSUITEXA20210 2021 Medis Suite XA is indicated for use in clinical settings where validated and rep Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by Medis Suite XA are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. LLZ System, Image Processing, Radiological 2 Medis Suite XA
13 B141MEDISSUITEXA20200 2020 Medis Suite XA is indicated for use in clinical settings where validated and rep Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. XA2D: When the quantified results provided by Medis Suite XA is used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.XA3D: When the quantified results provided by Medis Suite XA is used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians. LLZ System, Image Processing, Radiological 2 Medis Suite XA
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