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No Description
Garmin International, Inc.
1.x
In Commercial Distribution
- 00860009117716 ()
- Cardiopulmonary physiological parameter analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution
- 00860009117709 ()
- Cardiopulmonary physiological parameter analysis software
No Description
Deephealth, Inc.
2.1.0
In Commercial Distribution
- 00860005144020 ()
2.5
- Radiology DICOM image processing application software
The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on adult chest X- rays. This device is intended for use by licensed physicians who are trained in the evaluation of breathing tube placement on chest X-rays. The qXR-BT image provides adjunctive information and is not a substitute for the original PA/AP image.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
1.0.0
In Commercial Distribution
- 00860005118144 ()
- Radiology DICOM image processing application software
The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures from a set of Non-Contrast head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on NCCT images.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
1.0.0
In Commercial Distribution
- 00860005118137 ()
- Radiology DICOM image processing application software
No Description
CORTECHS LABS INC
NQ BT
In Commercial Distribution
- 00860000004824 ()
- MRI system application software
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