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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
Sunquest Mitogen™ Genetics supports laboratories in the management of patient genetic testing data, support reporting that includes variant information, and to transfer, store, and display test results and information.
CliniSys, Inc
6.3
Not in Commercial Distribution
- B236SMG6300 ()
- Human genomic analysis interpretive software
No Description
CLEAR GUIDE MEDICAL, INC.
CGONE
In Commercial Distribution
- B201CGONE1 ()
- B201CGONE0 ()
- Ultrasound imaging 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
CLEW MEDICAL LTD
4.8
In Commercial Distribution
- 07290018852002 ()
- Clinical management support software
The Diary is a mobile app intended for use by people with diabetes, in order to log, track and share blood glucose levels, insulin delivery, physical activity, as well as carbs and meal information as part of the endo.digital Platform used by their healthcare provider. Diary also enables people to communicate with their healthcare provider.
The Diary mobile app also enables the patient to see their insulin treatment recommendations provided by their healthcare provider. The insulin treatment plan is approved by your healthcare provider and he/she may have been assisted by the endo.digital algorithm before approving the plan.
The Diary Mobile app is suited for both iPhone and Android users.
The Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above
the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information.
The initial setup of the user’s treatment plans, and bolus calculator settings must be performed by a healthcare provider.
DREAMED DIABETES LTD
02.XX.YY
In Commercial Distribution
- 07290017735030 ()
N/A
- Clinical management support software
The iQMR is a software package, connected to the clinic LAN, that receive and transfer MRI images.
The image processing provide enhanced quality by reducing the image noise level.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.2
In Commercial Distribution
- 07290016836400 ()
- MRI system application software
Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
Opgen, Inc.
CP3511
Not in Commercial Distribution
- 20812125010086 ()
CP3511
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by DI-60 with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
AG516335
In Commercial Distribution
- 07350040975930 ()
AG516335
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-EN0099
In Commercial Distribution
- 07350040975923 ()
CRRS-GR0099
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-GR0099
In Commercial Distribution
- 07350040975916 ()
CRRS-GR0099
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-TE0099
In Commercial Distribution
- 07350040975909 ()
CRRS-TE0099
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-PR0099
In Commercial Distribution
- 07350040975893 ()
CRRS-PR0099
- Laboratory instrument/analyser application software IVD
When implemented together with DI-60 and software, the Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics
Cellavision AB
AB859211
In Commercial Distribution
- 07350040974759 ()
AB859211
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by DI-60 with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
BC188562
In Commercial Distribution
- 07350040974728 ()
BC188562
- Laboratory instrument/analyser application software IVD
The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
Cellavision AB
AG241722
In Commercial Distribution
- 07350040974704 ()
AG241722
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by DI-60 with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
AD742566
In Commercial Distribution
- 07350040974698 ()
AD742566
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable up to 5 concurrent remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-TE6099
Not in Commercial Distribution
- 07350040974599 ()
CRRS-TE6099
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-GRTE99
In Commercial Distribution
- 07350040974575 ()
CRRS-GRTE99
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable up to 25 concurrent remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-GR6099
Not in Commercial Distribution
- 07350040974568 ()
CRRS-GR6099
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-ENTE99
In Commercial Distribution
- 07350040974551 ()
CRRS-ENTE99
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-ENGR99
In Commercial Distribution
- 07350040974544 ()
CRRS-GRGR99
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable up to 75 concurrent remote users to access data collected, stored and processed by CellaVision DM instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-EN6099
Not in Commercial Distribution
- 07350040974537 ()
CRRS-EN6099
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-006099
Not in Commercial Distribution
- 07350040974513 ()
CRRS-006099
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-006001
Not in Commercial Distribution
- 07350040974506 ()
CRRS-006001
- Laboratory instrument/analyser application software IVD
The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
Cellavision AB
CBF-970099
In Commercial Distribution
- 07350040973776 ()
CBF-970099
- Laboratory instrument/analyser application software IVD
When implemented together with CellaVision DM9600 and software, the CellaVision Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics
Cellavision AB
CAR-970099
In Commercial Distribution
- 07350040973769 ()
CAR-970099
- Laboratory instrument/analyser application software IVD
When implemented together with CellaVision DM96 and software, the CellaVision Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics
Cellavision AB
CAR-960099
In Commercial Distribution
- 07350040973752 ()
CAR-960099
- Laboratory instrument/analyser application software IVD
When implemented together with CellaVision DM1200 and software, the CellaVision Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics
Cellavision AB
CAR-120099
In Commercial Distribution
- 07350040973745 ()
CAR-120099
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-005099
Not in Commercial Distribution
- 07350040973714 ()
CRRS-005099
- Laboratory instrument/analyser application software IVD
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-005001
Not in Commercial Distribution
- 07350040973707 ()
CRRS-005001
- Laboratory instrument/analyser application software IVD
The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
Cellavision AB
CBF-960099
In Commercial Distribution
- 07350040972564 ()
CBF-960099
- Laboratory instrument/analyser application software IVD
The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
Cellavision AB
CBF-120099
In Commercial Distribution
- 07350040972557 ()
CBF-120099
- Laboratory instrument/analyser application software IVD
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
75751
- 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
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution
- 07392532242380 ()
75751
- Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution
- 07392532242373 ()
75750
- Rectal irrigation 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 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