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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
- 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
- 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
- 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
- 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
- Laboratory instrument/analyser application software IVD
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 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 quantification
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, and
- to support the evaluation of interventions or drug therapy applied for conditions of the heart and vessels.
Medis Medical Imaging Systems B.V.
2.1
In Commercial Distribution
- B141MEDISSUITEMRCT210 ()
- 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 2023 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 2023 allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT 2023 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 2023 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.
2023
- 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 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.
Medis Medical Imaging Systems B.V.
2021
- Laboratory instrument/analyser application software IVD
Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution
- 10385083000565 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Pod
Insulet Corporation
POD-OMNI-I1-6720
In Commercial Distribution
- 20385083000531 ()
- 10385083000527 ()
- 20385083000579 ()
- 20385083000753 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Starter Kit mg/dl
Insulet Corporation
SKT-M001-G-X9
In Commercial Distribution
- 10385083000503 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution
- 10385083000336 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Pod
Insulet Corporation
POD-BLE-H1-520
In Commercial Distribution
- 10385083000213 ()
- 10385083000114 ()
- 10385083000138 ()
- 20385083000210 ()
- 20385083000135 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller (PDM) mg/dl - English with PodPals
Insulet Corporation
PDM-H001-G-XX
In Commercial Distribution
- 10385083000022 ()
- 30385083000019 ()
- 30385083000095 ()
SKT-H001-G-X9
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution
- 10385081120302 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
GlucoCare Intensive Glycemic Control System
Pronia Medical Systems Inc.
2.X
In Commercial Distribution
- G111GCR2 ()
- Clinical management support 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
SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD).
SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI.
SyMRI can also generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment.
SyMRI is indicated for head imaging.
When interpreted by a trained physician, output from SyMRI can provide information useful in determining diagnosis. SyMRI 2D is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR). T1W and T2W images from SyMRI 3D may replace conventional MR images in a clinical setting when interpreting together with a conventional 3D T2W FLAIR image.
SyntheticMR AB (publ)
15
In Commercial Distribution
- 07340024700078 ()
- MRI system application software
SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD).
SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI.
When interpreted by a trained physician, the parametric maps, tissue maps, and volumetrics from SyMRI can provide information useful in determining diagnosis. SyMRI is indicated for head imaging.
SyMRI can also generate multiple contrast weighted images from the parametric maps generated by post-processing data from M2D-MDME sequence. SyMRI enables post-acquisition image contrasts adjustments from acquisition using M2D-MDME sequence.
When M2D-MDME acquisition data is used as input to SyMRI the synthetic contrast weighted images can also provide information useful in determining diagnosis. SyMRI is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
14
In Commercial Distribution
- 07340024700061 ()
- MRI system application software
SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging.
SyMRI is also intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME images.
When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
11
In Commercial Distribution
- 07340024700030 ()
- MRI system application software
SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging.
When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
10
In Commercial Distribution
- 07340024700023 ()
- MRI system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
75751
- Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
75750
- Rectal irrigation system application software
Phadia Prime
Phadia AB
12-4101-00
In Commercial Distribution
- 07333066015101 ()
12-4101-00
- Laboratory instrument/analyser application software IVD
HemoCue® 801 Connect
Hemocue AB
139168
Not in Commercial Distribution
- 07311091391681 ()
139168
- Laboratory instrument/analyser application software IVD
No Description
Epocal Inc
SD-0004-00-00
Not in Commercial Distribution
- 00809708114572 ()
- Laboratory instrument/analyser application software IVD