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Software for cardiac image analysis.
Medviso AB
2
In Commercial Distribution
- 07350010100027 ()
- MRI system application software
Software for medical image analysis.
Medviso AB
2
In Commercial Distribution
- 07350010100010 ()
- Radiology DICOM image processing application software
MRI Planner is a stand alone software product intended to enable a completely MRI only workflow in
radiotherapy planning. The MRI Planner software achieves this by analyzing a dedicated MR
image and generating a synthetic CT image that can replace the conventional CT in the treatment
planning process. In addition, the software also performs automated contouring of risk organs in
certain anatomies. In the current version of MRI Planner, synthetic CT generation is supported for
the brain, head-neck and pelvis anatomies, whereas automated risk organ contouring is
supported for bladder, colon and femoral heads for prostate cancer patients only.
Spectronic Medical AB
2
In Commercial Distribution
- 07350097430017 ()
- Radiation therapy software
The Sectra Calibration Unit consists of calibration holders and markers.
The calibration holders are intended to correctly place the calibration markers in relation to the patient during image acquisition.
The calibration markers will be visible on the x-ray images and are intended to serve as scaling references.
Typical users of the device are trained professionals, for example radiology technicians.
Sectra AB
2
In Commercial Distribution
- 07350092810395 ()
- General-purpose diagnostic x-ray phantom, test object
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
KIT, LARGE. Includes: 100 - BLOCK, TORSO, 7” x 12” x 16” (00810050243049), 101 - BLOCK, BASALAR, 7” x 16” x 12” (00810050240987), 102 - HOLDER, ADULT AP-PA HEAD (00810050241205), 104 - BLOCK, PRESSURE, 5.5” x 7.38” x 10” (00810050241069), 105 - WEDGE, 3.75” x 9” x 8” (10810050242995), 106 - WEDGE, 6.63” x 6.63” x 12” (00810050242318), 169 - RECTANGLE, 3” x 7.5” x 10” (00810050240413)
DOMICO MED-DEVICE, LLC
2
In Commercial Distribution
- 00810050243254 ()
- Multifunction body cushion
- Radiological general body-part positioner
- Radiological headrest
The Idylla MSI Test, for use on the Idylla System, uses formalin-fixed, paraffin embedded (FFPE) tissue sections of human CRC tumor, from which nucleic acids are liberated, then analyzed using PCR amplification of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) and subsequent melt-curve analysis. The Idylla MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid.
Biocartis NV
2
In Commercial Distribution
- 15415219000758 ()
- 05415219000751 ()
- Microsatellite instability IVD, kit, nucleic acid technique (NAT)
moorFLPI2- Measurement PC Software V2
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution
- 15060484490126 ()
- Cutaneous microcirculation laser Doppler imaging device
Clinical software for micro vascular assessments in physiological research and clinical applications.
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution
- 15060484490102 ()
- Laser Doppler blood flowmeter
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote
viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
2
In Commercial Distribution
- 17290016976004 ()
- Colposcope