EchoGo Core (2.0)
Ultromics LimitedEchoGo Core (2.0) is an AI-powered software that analyzes ultrasound images of the heart (echocardiograms) to automatically quantify and report cardiac function metrics. It assists physicians by providing measurements like ejection fraction, ventricular volume, and strain, helping in cardiovascular diagnosis for adult patients.
Intended Use
EchoGo Core is intended to be used for quantification and reporting of results of cardiovascular function to support physician diagnosis in adult populations.
Technology
EchoGo Core 2.0 is a software application that uses AI for operator-assisted automatic quantification of echocardiographic metrics from ultrasound images, producing reports in DICOM formats. It operates sequentially with steps including view classification, LV segmentation, cycle and frame selection, and clinical report generation. Operators confirm or adjust AI outputs.
Performance
Software underwent rigorous verification and validation including unit, module, and system integration testing. Performance was evaluated against a predicate device and comparator device TomTec Arena TTA2 using 214 unseen studies, showing substantial equivalence in measuring cardiac function metrics with root mean square errors within acceptable predefined thresholds. Inter- and intra-operator variability were low, demonstrating robust repeatability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2021
2 months - 2
FDA Approval
12/20/2021
Other devices from Ultromics Limited
- EchoGo Amyloidosis (1.0)2024 • 510K
- EchoGo Heart Failure (2.0)2024 • 510K
- EchoGo Pro2020 • 510K
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