Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Type Device Class Implantable

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No Description
Roche Molecular Systems, Inc.
08302375001
Not in Commercial Distribution

  • 07613336150047 ()
08302375001

  • Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08085471001
In Commercial Distribution

  • 07613336129692 ()
08085471001

  • Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08085463001
In Commercial Distribution

  • 07613336129685 ()
08085463001

  • Laboratory instrument/analyser application software IVD
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.
Medis Medical Imaging Systems B.V.
7.3
In Commercial Distribution

  • B141QANGIOXA730 ()


  • Laboratory instrument/analyser application software IVD
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
Medis Medical Imaging Systems B.V.
2019
In Commercial Distribution



  • Laboratory instrument/analyser application software IVD
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
Medis Medical Imaging Systems B.V.
2018
In Commercial Distribution



  • Laboratory instrument/analyser application software IVD
Medis Suite XA 2023 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 2023 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.
Medis Medical Imaging Systems B.V.
2023
In Commercial Distribution



  • Laboratory instrument/analyser application software IVD
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.
Medis Medical Imaging Systems B.V.
2022
In Commercial Distribution



  • Laboratory instrument/analyser application software IVD
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.
Medis Medical Imaging Systems B.V.
2021
In Commercial Distribution



  • Laboratory instrument/analyser application software IVD
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.
Medis Medical Imaging Systems B.V.
2020
In Commercial Distribution



  • Laboratory instrument/analyser application software IVD
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