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The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provide a notification to the user.
The Fitbit Irregular Rhythm Notifications is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the Fitbit Irregular Rhythm Notifications is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis.
These data are only captured when the user is still. Along with the user’s risk factors, the Fitbit Irregular Rhythm Notifications can be used to supplement the decision for AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace traditional methods of diagnosis or treatment.
The Fitbit Irregular Rhythm Notifications has not been tested for and is not intended for use
in people under 22 years of age. It is also not intended for use in individuals previously
diagnosed with AFib.
FITBIT, INC.
FB604
In Commercial Distribution
- 00810038852720 ()
FB604
- Cardiopulmonary physiological parameter analysis software
ORTHONOL(R) PREFORM NATURAL ARCH MX .017 X .025 34MM
Rmo, Inc.
A07075
In Commercial Distribution
- 00000008857972 ()
- 00885797019837 ()
- Orthodontic archwire
No Description
Prowess, Inc.
v5.61
In Commercial Distribution
- 00859032007088 ()
- Radiation therapy software
Littmann® Stethassist Heart And Lung Sound Visualization Software
3M COMPANY
ES1000
In Commercial Distribution
- 00707387779054 ()
ES1000
- Stethoscope application software
No Description
Disior Oy
Bonelogic 2.2
In Commercial Distribution
- 06429810209221 ()
- CAD/CAM software
No Description
Disior Oy
Bonelogic 2
In Commercial Distribution
- 06429810209023 ()
- CAD/CAM software
The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatment response assessment of oncological diseases. Fields of application are radiological diagnosis and follow-up examinations in oncology, as well as clinical or pharmaceutical drug trials across a defined group of patients.
mint Lesion implements various radiological guidelines and response evaluation criteria, such as RECIST (Response Evaluation Criteria In Solid Tumors). This also includes the assessment of the stage of oncological disease (staging) and the objective response to therapy (e.g. timepoint response / overall response). The timepoint response is an empirical measure to evaluate therapy success according to the response criteria in use. It is mainly used to assess patient cohorts in the course of clinical trials of novel therapy agents. The timepoint response may differ from a radiological assessment of response to therapy and must not be used as a surrogate.
mint Lesion allows for the documentation of size and assessment of changes in size of solid tumors described by the respective criteria that are monitored by means of radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine (PET, NM), digital radiography (XR, CR)).
mint Lesion follows the typical workflow of follow-up examinations, from assessment to reporting, and enables the integration of a clinical-radiological software environment (PACS, Picture Archiving and Communication System). Assessment results can be exported into different electronical formats and processed further by other applications.
Mint Medical GmbH
3.3.0
In Commercial Distribution
- 14260495880331 ()
- Radiological PACS software
The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
• Retrieve image data over the network via DICOM
• Display of images in dedicated protocols which are automatically adapted based on exam type
• Select images for closer examination from a gallery of 2D or 3D views
• Interactively manipulate an image in real-time to visualize anatomy and pathology
• Annotate, measure, and record selected views
• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device
• Retrieve reports that are archived on a Web server
Canon Medical Informatics, Inc.
7.12.6
In Commercial Distribution
- 00853866003995 ()
- Radiological PACS software
The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
• Retrieve image data over the network via DICOM
• Display of images in dedicated protocols which are automatically adapted based on exam type
• Select images for closer examination from a gallery of 2D or 3D views
• Interactively manipulate an image in real-time to visualize anatomy and pathology
• Annotate, measure, and record selected views
• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device
• Retrieve reports that are archived on a Web server
Canon Medical Informatics, Inc.
7.14.2
In Commercial Distribution
- 00853866003988 ()
- Radiological PACS software
The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
• Retrieve image data over the network via DICOM
• Display of images in dedicated protocols which are automatically adapted based on exam type
• Select images for closer examination from a gallery of 2D or 3D views
• Interactively manipulate an image in real-time to visualize anatomy and pathology
• Annotate, measure, and record selected views
• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device
• Retrieve reports that are archived on a Web server
Canon Medical Informatics, Inc.
7.12.5
In Commercial Distribution
- 00853866003971 ()
- Radiological PACS software