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Glooko Web Application is a web based application that displays and analyzes retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
xx.yy (xx is model year and yy is a serial number)
In Commercial Distribution
- 00855093008026 ()
- Clinical management support software
Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the prescribers on standard web browsers.
GLOOKO, INC.
18.x
In Commercial Distribution
- 00855093008019 ()
- Clinical management support software
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution
- 00855093008002 ()
- Clinical management support software
Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.
AMBIENT CLINICAL ANALYTICS, INC.
1.0
In Commercial Distribution
- 00850893007033 ()
- Clinical management support software
Clinical decision support software for disease detection and response indicated for use by licensed clinicians in a clinical setting.
AMBIENT CLINICAL ANALYTICS, INC.
1.1
In Commercial Distribution
- 00850893007026 ()
- Clinical management support software
Clinical decision support software indicated for use by licensed clinicians in a clinical setting integrated with Philips ICCA product.
AMBIENT CLINICAL ANALYTICS, INC.
P1.0
In Commercial Distribution
- 00850893007019 ()
- Clinical management support software
No Description
AMBIENT CLINICAL ANALYTICS, INC.
1.1
In Commercial Distribution
- 00850893007002 ()
- Clinical management support software
Hypotension Decision Assist HDA-OR2 is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a
medically-rated touch-screen tablet computer. HDA-OR2 connects to a multi-parameter patient monitor supplied by other manufacturers, from
which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric
parameters. HDA-OR2 continually processes this data to display, in graphical charts and numeric format, vital signs data and derived
variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic
vascular resistance. HDA-OR2 compares MAP to user set targets to indicate when MAP is above or below the target range. It allows
the user to mark the administration of vasopressors and volume challenges to the MAP trend.
DIRECTED SYSTEMS LIMITED
HDA-OR2
In Commercial Distribution
- 00860003496718 ()
- Clinical management support software
Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer. HDA connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters.
HDA continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.
DIRECTED SYSTEMS LIMITED
HDA-OR1
In Commercial Distribution
- 00860003496701 ()
- Clinical management support software
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques.
Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution
- 00860002545707 ()
- Ultrasound imaging system application software