LVivo Software Application
DiA Imaging Analysis LtdThe LVivo Software Application is an AI-powered tool that automates the analysis of ultrasound images, specifically echocardiograms, to measure cardiac functions such as left and right ventricular function and bladder volume. It helps clinicians accurately and efficiently assess heart structure and function in patients, supporting better diagnosis and management of heart conditions.
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.
Technology
The LVivo Software Application automates analysis of echocardiographic ultrasound DICOM images to evaluate left and right ventricular function, including global and segmental assessments using multiple apical views and parasternal short axis views. It includes modules for ejection fraction measurement, wall motion, and strain analysis, with options for manual adjustment and visual confirmation.
Performance
Performance evaluation was conducted using a dataset of 100 patients’ transthoracic echocardiograms, demonstrating acceptable correlation and sensitivity of ejection fraction and strain measurements compared to reference standards. The software met predefined acceptance criteria for key cardiac measurements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/8/2021
28 days - 2
FDA Approval
2/5/2021
Other devices from DiA Imaging Analysis Ltd
- LVivo Software Application2024 • 510K
- LVivo IQS2024 • 510K
- LVivo IQS2023 • 510K
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