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BriefCase is a radiological computer aided triage and notification software device.
The device contains the software platform and image analysis algorithms for ICH, PE and CSF triage.
AIDOC MEDICAL LTD
3.0.0
Not in Commercial Distribution
- 07290018052044 ()
- Radiology DICOM image processing application 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
No Description
NANO-X AI LTD
3.0.0
In Commercial Distribution
- 07290018016053 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.0.0
Not in Commercial Distribution
- 07290018016046 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
2.1.3
Not in Commercial Distribution
- 07290018016039 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
2.0.5
In Commercial Distribution
- 07290018016022 ()
- Radiology DICOM image processing application software
No Description
NANO-X AI LTD
1.0.6
Not in Commercial Distribution
- 07290018016015 ()
- Radiology DICOM image processing application software
No Description
MEDICAL FEEDBACK TECHNOLOGIES LTD
BE8789US
In Commercial Distribution
- 17290017875009 ()
- 07290017875002 ()
- Cardiopulmonary resuscitation feedback device, electronic
The FFRangio System is a non invasive image based software device
CATHWORKS LTD
FAU04000
In Commercial Distribution
- 17290017855056 ()
- 07290017855059 ()
FAU04000
- Diagnostic x-ray digital imaging system workstation
The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of a coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The FFRangio™ System performs all required processing and calculations based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure.
CATHWORKS LTD
FAU01000
In Commercial Distribution
- 17290017855025 ()
- 07290017855028 ()
FAU01000
- Diagnostic x-ray digital imaging system workstation
No Description
Naturalcycles Nordic AB
V5.4.0
In Commercial Distribution
- 07350014630339 ()
- Self-care monitoring/reporting software
No Description
Naturalcycles Nordic AB
V5.0
In Commercial Distribution
- 07350014630285 ()
- Self-care monitoring/reporting software
Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Naturalcycles Nordic AB
13
In Commercial Distribution
- 07350014630131 ()
- Self-care monitoring/reporting software
No Description
Naturalcycles Nordic AB
B
In Commercial Distribution
- 07350014630124 ()
- Self-care monitoring/reporting 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