Us2.v1 is an AI-powered software platform that automatically processes and analyzes transthoracic cardiac ultrasound images to measure key cardiac structural and functional parameters. It helps cardiologists and healthcare providers by producing comprehensive reports to support clinical decision-making for adult patients.
Intended Use
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 is intended to support qualified cardiologists or licensed primary care providers for clinical decision-making.
Technology
Software performs automated and manual markup and quantitative analysis of echocardiographic images in DICOM format using machine learning for view classification and border detection. It runs on off-the-shelf hardware and integrates with PACS. The automation level includes fully automated clip selection and calculations of multiple cardiac function measurements.
Performance
Us2.v1 underwent extensive non-clinical verification, validation, risk management, cybersecurity analysis, and usability studies. A formal retrospective validation study with 600 echocardiograms compared software measurements to human expert readings, demonstrating non-inferiority within a prespecified margin for multiple cardiac measurements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/16/2021
4 months - 2
FDA Approval
7/27/2021
Other devices from eko.ai Pte. Ltd. d/b/a Us2.ai
- Us2.v22024 • 510K
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