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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
No Description
CLEAR GUIDE MEDICAL, INC.
CGONE
In Commercial Distribution
- B201CGONE1 ()
- B201CGONE0 ()
- Ultrasound imaging system application software
NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.75.20171019
In Commercial Distribution
- B133NEUROQ1 ()
- Neurosurgical ultrasound navigation system application software
NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.6.20131127
In Commercial Distribution
- B133NEUROQ0 ()
- Neurosurgical ultrasound navigation 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
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