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Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients.
Please note the following limitations:
• Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality.
• Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make
appropriate clinical decisions.
• If no gender is present, female referenced guideline values will be used for conclusions.
• If Body Surface Area (BSA) is not present, indexed values cannot be provided.
• During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of
electrocardiogram capture may lead to lower accuracy of the software.
EKO.AI PTE. LTD.
2
In Commercial Distribution
- 00860005876815 ()
- Radiology DICOM image processing application software
Us2.v1 is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease and/or intra-cardiac lesions (e.g tumors, thrombi).
Please note the following limitations:
- Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality.
- Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions.
- If no gender is present, female referenced guideline values will be used for conclusions.
- If Body Surface Area (BSA) is not present, indexed values cannot be provided.
- During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
EKO.AI PTE. LTD.
1
In Commercial Distribution
- 00860005876808 ()
- Radiology DICOM image processing application software
Software application that uses machine learning to assess breast tissue composition.
Ai Whiterabbit Inc
WRDensity-1
In Commercial Distribution
- 00860005853601 ()
- Radiology DICOM image processing application software
No Description
Overjet, Inc.
v1
In Commercial Distribution
- 00860005586356 ()
- Dental x-ray image interpretive software
The PHA Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The PHA Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
Imbio, LLC
4.0.0
In Commercial Distribution
- 00850894007902 ()
- X-ray image interpretive software
ClearPoint Maestro Brain Model Software Version 1.0
Clearpoint Neuro, Inc.
CPM-SFW-1
In Commercial Distribution
- 00850359007966 ()
CPM-SFW-1
- Image segmentation application software
qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans.
qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm.
The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
1.0.0
In Commercial Distribution
- 00850057636000 ()
- Radiology DICOM image processing application software
FEops HEARTguide ALPACA
FEops
3.1.0
In Commercial Distribution
- 05430002070087 ()
05430002070087
- Radiology DICOM image processing application software
FEops HEARTguide ALPACA 3.0.1 / 3.0.2
FEops
3.0.1
Not in Commercial Distribution
- 05430002070063 ()
- Radiology DICOM image processing application software
No Description
Disior Oy
1.0
In Commercial Distribution
- 06429810209047 ()
- CAD/CAM software