LVivo IQS
DiA Imaging Analysis LtdLVivo IQS is a software application that processes ultrasound images of the heart to detect, measure, and calculate key medical parameters for patients with suspected cardiac disease. It provides real-time quality score feedback on image quality, helping clinicians ensure the accuracy and usefulness of cardiac ultrasound scans, particularly the left ventricle function from the 4 chamber apical view. This tool assists clinicians by improving the reliability of echocardiographic assessments.
Intended Use
LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
Technology
LVivo IQS is an extension module to the LVivo Software Application, employing an algorithm and API to provide real-time Quality Score feedback for the Left Ventricle using the 4 chamber apical ultrasound view. It is provided as a software component integrated into legally marketed ultrasound devices. The technology is substantially equivalent to its predicate with the added Quality Score feedback functionality.
Performance
Performance validation included testing against expert sonographer quality tagging on 100 patient exams with 22,663 frames analyzed showing 81% agreement. Additional testing in real-time Point-Of-Care Ultrasound settings with 64 patients showed that 90% of images visually estimated as moderate to good quality were classified as 'Medium' or better quality by LVivo IQS, with 93% of these clips clinically interpretable by experts.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2022
4 months - 2
FDA Approval
2/1/2023
Other devices from DiA Imaging Analysis Ltd
- LVivo Software Application2024 • 510K
- LVivo IQS2024 • 510K
- LVivo Seamless2021 • 510K
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