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BriefCase is a radiological computer aided triage and notification software device. Software version 3.0.0 for CSF triage
AIDOC MEDICAL LTD
3.0.0
Not in Commercial Distribution
- 07290018052037 ()
- Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software device. Software version 2.0.0 for PE triage
AIDOC MEDICAL LTD
2.0.0
Not in Commercial Distribution
- 07290018052020 ()
- Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software device. Software version 1.1.0.0 for ICH triage.
AIDOC MEDICAL LTD
1.1.0.0
Not in Commercial Distribution
- 07290018052013 ()
- Radiology DICOM image processing application software
No Description
HEALTHCARE ID, INC.
3.3.5
In Commercial Distribution
- 1928342896382000 ()
- Configurable electronic form web-based application software
Donor-ID 3.3.4.0
HEALTHCARE ID, INC.
3.3.4.0
In Commercial Distribution
- 1928342896381900 ()
- Configurable electronic form web-based application software
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
No Description
NANO-X AI LTD
1.0
In Commercial Distribution
- 07290018016107 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.0
Not in Commercial Distribution
- 07290018016084 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
2.0.0
In Commercial Distribution
- 07290018016077 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
2.2
In Commercial Distribution
- 07290018016060 ()
- Radiology DICOM image processing application software