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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.
Medis Medical Imaging Systems B.V.
2.0
In Commercial Distribution
- B141MEDISSUITEXA20190 ()
- Laboratory instrument/analyser application software IVD
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 fluid
These 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.
Medis Medical Imaging Systems B.V.
3.0
- Laboratory instrument/analyser application software IVD
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.
Medis Medical Imaging Systems B.V.
2025
- Laboratory instrument/analyser application software IVD
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.
Medis Medical Imaging Systems B.V.
2022
- Laboratory instrument/analyser application software IVD
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.
Medis Medical Imaging Systems B.V.
2020
- Laboratory instrument/analyser application software IVD
No Description
STRYKER CORPORATION
0240060145
In Commercial Distribution
- 07613327311846 ()
0240-060-145
- Operating room audiovisual data/device management system application software
No Description
STRYKER CORPORATION
0240060140
In Commercial Distribution
- 07613327311839 ()
0240-060-140
- Operating room audiovisual data/device management system application software
LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician.
LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed.
The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.
Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy.
Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision.
PERSPECTUM LTD
2.0
In Commercial Distribution
- B554LMS2000 ()
- MRI system application software
No Description
Roche Molecular Systems, Inc.
08403864001
Not in Commercial Distribution
- 07613336156551 ()
08403864001
- Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08403856001
In Commercial Distribution
- 07613336156544 ()
08403856001
- Laboratory instrument/analyser application software IVD