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Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine leaming models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image.dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.8.X
In Commercial Distribution
- 00628011382184 ()
- Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.7.X
In Commercial Distribution
- 00628011382177 ()
- Radiation therapy software
Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution
- 09351356000055 ()
- Phonocardiograph
- Stethoscope application software
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution
- 09351356000048 ()
- Phonocardiograph
- Stethoscope application software
Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System.
The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution
- 09351356000031 ()
- Phonocardiograph
- Stethoscope application software
NeuroStar Mobile Console, recertified
NEURONETICS, INC.
3.X
In Commercial Distribution
- 00850005944430 ()
81-02315-00R
- Magnetic neural stimulation system
NeuroStar Mobile Console, recertified
NEURONETICS, INC.
2.X
In Commercial Distribution
- 00850005944423 ()
81-01315-00R
- Magnetic neural stimulation system
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution
- 00850010298146 ()
ELEFT
- Cardiopulmonary physiological parameter analysis software
Blackford Smart Localizer v1.4.x, supplied with Blackford Platform (part of the Blackford Product Family)- previously marketed as the Blackford Registration Application, released under evaluation only.
BLACKFORD ANALYSIS LIMITED
1.4.x
In Commercial Distribution
- 05060570830105 ()
- Radiological PACS software
Blackford Platform v2.3.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.3.x
In Commercial Distribution
- 05060570830099 ()
- Radiological PACS software
Blackford Platform v2.2.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.2.x
In Commercial Distribution
- 05060570830068 ()
- Radiological PACS software
Blackford Registration Application v1.3.x, supplied with Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.3.x
In Commercial Distribution
- 05060570830044 ()
- Radiological PACS software
Blackford Platform v2.1.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.1.x
In Commercial Distribution
- 05060570830037 ()
- Radiological PACS software
MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information.
The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.
MeVis BreastCare GmbH & Co. KG
1.1.x
In Commercial Distribution
- 04262459510028 ()
- Diagnostic x-ray digital imaging system workstation application software
MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information.
The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.
MeVis BreastCare GmbH & Co. KG
1.0.x
Not in Commercial Distribution
- 04262459510011 ()
- Diagnostic x-ray digital imaging system workstation application software
cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data.
cNeuro™ cDAT enables visual evaluation and quantification of 123 Ioflupane (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of 123 Ioflupane (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB).
cNeuro cDAT has not been demonstrated to improve 123 ioflupane reader performance for distinguishing positive from negative patients. This device should not be used to deviate from 123 ioflupane dosing and administration instructions. Refer also to 123 ioflupane prescribing information for instructions.
Combinostics Oy
1.0.x
In Commercial Distribution
- 06430070845012 ()
- Radiology DICOM image processing application software
cNeuro cPET aids physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans.
The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest and voxel-based maps of the brain. cNeuro cPET allows the user to generate information regarding relative changes in PET-FDG glucose metabolism.
cNeuro cPET additionally allows the user to generate information regarding relative changes in PET brain amyloid load between a subject’s images and a normal database, which may be the result of brain neurodegeneration.
PET co-registration and fusion display capabilities with MRI allow PET findings to be related to brain anatomy.
cNeuro cPET aids physicians in the image interpretation of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline.
Combinostics Oy
1.0.x
In Commercial Distribution
- 06430070844015 ()
- Radiology DICOM image processing application software
https://www.combinostics.com/cmri/
Combinostics Oy
2.0.X
In Commercial Distribution
- 06430070841021 ()
- Radiology DICOM image processing application software
No Description
PaloDEx Group Oy
6.x
In Commercial Distribution
- 06430035872367 ()
213248
- Stationary panoramic/tomographic dental x-ray system, digital
No Description
PaloDEx Group Oy
11.x
In Commercial Distribution
- 06430035872350 ()
213183
- Stationary panoramic/tomographic dental x-ray system, digital