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KARL STORZ OR1 SCB CONTROL
Karl Storz GmbH & Co. KG
WU300
In Commercial Distribution
- 04048551416778 ()
- Operating room audiovisual data/device management system application software
AIDA 2.0 Office 10 licences
Karl Storz GmbH & Co. KG
20040013-P10
In Commercial Distribution
- 04048551405734 ()
- Operating room audiovisual data/device management system application software
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0071-0101
In Commercial Distribution
- 04049016148708 ()
- Laboratory instrument/analyser application software IVD
CHECKLIST APP This app requires core.portal. The checklist app is a universal questionnaire and checklist system for collecting information during surgery. Checklists can be defined as customer-specific multilingual templates. The checklists are displayed in accordance with the language selected in the core.browser. The app generates a PDF report with the demographic patient data, information about the surgical intervention, a logo and the recorded data. The report is part of the documentation. The app does not spread the information collected.
Richard Wolf GmbH
5597706
Not in Commercial Distribution
- 04055207070086 ()
5597706
- Operating room audiovisual data/device management system application software
MEDIA ARCHIVE FILESHARE This module requires core.portal. It allows the storage of intraoperative data to an enabled directory in the hospital’s IT infrastructure. The module is required once for each file sharing approval.
Richard Wolf GmbH
5597203
Not in Commercial Distribution
- 04055207070079 ()
5597203
- Operating room audiovisual data/device management system application software
CORE.PORTAL SCHEDULING HL7 This module requires core.portal as a basis. It is used for transmitting demographic patient data or surgery scheduling data from a hospital information system via HL7 messages to core.portal. One module is required for each message type.
Richard Wolf GmbH
5597303
Not in Commercial Distribution
- 04055207070062 ()
5597303
- Operating room audiovisual data/device management system application software
Loudspeaker for KARL STORZ VOICE1®
Karl Storz GmbH & Co. KG
20090073
In Commercial Distribution
- 04048551006733 ()
- Operating room audiovisual data/device management system application software
EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display measurement results from point -of-care diagnostic testing analyzers. EKF Link enables the allocation of additional information to measurement results and facilitates the export or transfer of data for documentation purposes.
EKF Link is intended to be used as an optional software application with EKF point -of-care analyzers and open to be interfaced to other vendor’s point-of-care testing analyzers verified for connection with EKF Link.
EKF Link facilitates the setting of configurable options of connected analyzers.
EKF-diagnostic GmbH
0760-0101
In Commercial Distribution
- 04048534002011 ()
0760-0101
- Laboratory instrument/analyser application software IVD
Fetoly-Heart is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. Fetoly-Heart can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines.
DIAGNOLY
1
In Commercial Distribution
- 03770033463000 ()
- Ultrasound imaging system application software
Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol.
Sonio Detect receives fetal ultrasound images and clips from the ultrasound machine, that are submitted through the edge software by the performing healthcare professional, in real-time and performs the following:
Automatically detect views;
Automatically detect anatomical structures within the supported views;
Automatically verify quality criteria of the supported views by checking whether they conform to standardized quality criteria
SONIO
2
In Commercial Distribution
- 03770024341041 ()
- Ultrasound imaging system application software
Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN
MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following)
to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by
Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and
Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in
assuring during and after their examination that the examination is complete and all images were
collected according to their protocol.
SONIO
1
In Commercial Distribution
- 03770024341027 ()
- Ultrasound imaging system application software
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
- 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
- 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
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
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.
2019
- 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.
2018
- Laboratory instrument/analyser application software IVD
No Description
Roche Diagnostics GmbH
09220763001
In Commercial Distribution
- 07613336192429 ()
09220763001
- Laboratory instrument/analyser application software IVD
No Description
DIASORIN SPA
Q0001
In Commercial Distribution
- 08056771103572 ()
- Laboratory instrument/analyser application software IVD
GlucoCare Intensive Glycemic Control System
Pronia Medical Systems Inc.
2.X
In Commercial Distribution
- G111GCR2 ()
- Clinical management support software
Installation Kit for QVCAD System Release 3.4.6 with Debian 12.2
QVIEW MEDICAL
12.02-3.4.6
- Ultrasound imaging system application software
Installation Kit for QVCAD System Release 3.4.4 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.4
- Ultrasound imaging system application software
Installation Kit for QVCAD System Release 3.4.3 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.3
In Commercial Distribution
- B630QVCSIK1010343 ()
- Ultrasound imaging system application software
Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.6
- Ultrasound imaging system application software
Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.4
- Ultrasound imaging system application software
No Description
QVIEW MEDICAL
3.4.3
In Commercial Distribution
- B630QVCS343 ()
- Ultrasound imaging system application software
No Description
QVIEW MEDICAL
3.4.2
- Ultrasound imaging system application software
No Description
QVIEW MEDICAL
3.4
- Ultrasound imaging system application software
No Description
QVIEW MEDICAL
3.3
In Commercial Distribution
- B630QVCS33 ()
- Ultrasound imaging system application software