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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
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
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
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
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
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO: Universal 3.0 packed kit for Quest Diagnostics - 3 tests
In Commercial Distribution
- 07290016650792 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO: Universal 3.0 packed kit for Bird & Be - 3 tests
In Commercial Distribution
- 07290016650785 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO: Universal 3.0 packed kit for PROOV - 3 tests
In Commercial Distribution
- 07290016650778 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO 3.0: Refill Pack of 3 Tests
In Commercial Distribution
- 07290016650761 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO 3.0
In Commercial Distribution
- 07290016650754 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO Universal 2.0 packed kit for BirdandBe - 2 tests
In Commercial Distribution
- 07290016650587 ()
YO-FA-01912-00
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO: Universal 2.0 packed kit - 6 tests
In Commercial Distribution
- 07290016650365 ()
YO-FA-01635-00
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO: Universal 2.0 packed kit - 4 tests
In Commercial Distribution
- 07290016650358 ()
YO-FA-01634-00
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO: Universal 2.0 packed kit - 2 tests
In Commercial Distribution
- 07290016650341 ()
YO-FA-01633-00
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For YO Universal 1.0
In Commercial Distribution
- 07290016650273 ()
YO-FA-01469-00
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For iPhone 8 Plus
In Commercial Distribution
- 07290016650266 ()
YO-FA-01476-00
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For iPhone 8
In Commercial Distribution
- 07290016650259 ()
YO-FA-01480-00
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy J7
In Commercial Distribution
- 07290016650242 ()
YO-FA-01429-00
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For iPhone X
In Commercial Distribution
- 07290016650235 ()
YO-FA-01475-00
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For iPhone 7 Plus
In Commercial Distribution
- 07290016650228 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy J2
In Commercial Distribution
- 07290016650211 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Xiaomi mi 5
Not in Commercial Distribution
- 07290016650204 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy S8 plus
In Commercial Distribution
- 07290016650198 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy S8
In Commercial Distribution
- 07290016650181 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Huawei Honor 6
In Commercial Distribution
- 07290016650174 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Huawei Mate 9
In Commercial Distribution
- 07290016650167 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Xiaomi Note 4
In Commercial Distribution
- 07290016650150 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For LG G6
In Commercial Distribution
- 07290016650143 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For LG G5
In Commercial Distribution
- 07290016650136 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Iphone 6 plus/ 6s plus/ 7 plus
In Commercial Distribution
- 07290016650112 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 7 Edge
In Commercial Distribution
- 07290016650105 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 7
Not in Commercial Distribution
- 07290016650082 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 6
In Commercial Distribution
- 07290016650075 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For I-Phone 7
In Commercial Distribution
- 07290016650068 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For I-Phone 6
In Commercial Distribution
- 07290016650051 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For I-Phone 5/5S/SE
In Commercial Distribution
- 07290012140983 ()
- Motile sperm concentration IVD, kit, imaging, self-testing
nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines, which are executed automatically when image data is received or manually by a user. The user can choose to send the results to other DICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities.
nordicMEDiVA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Software as a Service (SaaS) hosted by NordicImagingLab AS in the cloud. Customers can install the server on physical hardware or in their own cloud infrastructure.
The device comprises a database, DICOM functionality, various APIs, a visualization engine, and medical image analysis modules. The device is not intended for long-term persistent storage of medical diagnostic data.
The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks.
The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.
Nordicneurolab AS
3
In Commercial Distribution
- 07090042059084 ()
- MRI system application software
nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines, which are executed automatically when image data is received or manually by a user. The user can choose to send the results to other DICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities.
nordicMEDiVA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Software as a Service (SaaS) hosted by NordicImagingLab AS in the cloud. Customers can install the server on physical hardware, virtual machines, or in their own cloud infrastructure.
The device comprises a database, DICOM functionality, various APIs, a visualization engine, and medical image analysis modules. The device is not intended for long-term persistent storage of medical diagnostic data.
The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks.
The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.
Nordicneurolab AS
2
In Commercial Distribution
- 07090042059077 ()
- MRI system application software
NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind.
With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition.
nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient.
Nordicneurolab AS
2.0
In Commercial Distribution
- 07090042059060 ()
- MRI system application software
nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynamic susceptibility contrast enhanced (DSC) perfusion data obtained
from Magnetic Resonance Imaging (MRI). The product can be deployed on the nordicMEDiVA platform, or as a plugin to other software offerings.
Nordicneurolab AS
23.04
In Commercial Distribution
- 07090042059053 ()
- MRI system application software
No Description
Nordicneurolab AS
1.1
In Commercial Distribution
- 07090042059046 ()
- MRI system application software
NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind.
With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition.
nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient.
Nordicneurolab AS
1.3
In Commercial Distribution
- 07090042059022 ()
- MRI system application software