LVivo Seamless
DiA Imaging Analysis LtdLVivo Seamless is an AI software application that automatically analyzes echocardiogram ultrasound images to assess cardiac function by calculating parameters like ejection fraction (EF). It helps clinicians by streamlining the evaluation process, sending analyzed results directly to PACS for review, enhancing diagnostic efficiency and accuracy for patients with suspected cardiac disease.
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
LVivo Seamless accepts DICOM ultrasound echo exams, automatically selects clips for EF evaluation, activates the FDA-cleared LVivo EF module for automatic cardiac function analysis, and sends results to PACS for clinician review. It runs offline on institutional servers.
Performance
Performance testing based on well-established methods demonstrated conformity to intended use with successful support of device performance, indicating no new safety or effectiveness concerns compared to predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/2/2020
27 days - 2
FDA Approval
9/29/2020
Other devices from DiA Imaging Analysis Ltd
- LVivo Software Application2024 • 510K
- LVivo IQS2024 • 510K
- LVivo IQS2023 • 510K
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