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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
Insulin Insights™ is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. Insulin Insights™ evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, height, and gender) and suggests changes (if necessary). Insulin Insights™ is designed for use by healthcare professionals. Insulin Insights™ is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs.
MELLITUS HEALTH, INC.
Version 1
In Commercial Distribution
- 00860001009804 ()
- Clinical management support software
Concentriq AP-Dx is a diagnostic software device for viewing and managing digital pathology slides from FFPE tissue. It aids pathologists in reviewing and interpreting digital slide images for primary diagnosis, specifically with Hamamatsu NanoZoomer S360MD scanner and JVC monitor. The software requires qualified pathologists to ensure image quality and interpretation validity. Not intended for frozen sections, cytology, or non-FFPE hematopathology specimens.
Proscia Inc.
DX040US
In Commercial Distribution
- 00860006054595 ()
4.8.1
- Laboratory instrument/analyser application software IVD
Localization and characterization of thyroid ultrasound images.
SEE-MODE TECHNOLOGIES PTE. LTD.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
In Commercial Distribution
- 00860006305727 ()
- Ultrasound imaging system application software
Analysis and reporting of vascular ultrasound images
SEE-MODE TECHNOLOGIES PTE. LTD.
AVA (Augmented Vascular Analysis)
In Commercial Distribution
- 00860006305703 ()
- Ultrasound imaging system application software
MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution
- 00860006066307 ()
- Ultrasound imaging system application software
Concentriq® AP-Dx is a software only device intended for viewing and management of digital images
of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is
an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of
primary diagnosis. Concentriq AP-Dx is not intended for use with frozen sections, cytology, or non-FFPE
hematopathology specimens.
Proscia Inc.
4.6
In Commercial Distribution
- 00860006054557 ()
US
- Laboratory instrument/analyser application software IVD
Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.
Proscia Inc.
4.5
In Commercial Distribution
- 00860006054519 ()
US
- Laboratory instrument/analyser application software IVD