Ventripoint Medical System Plus (VMS+) 3.0
Ventripoint Diagnostics, Ltd.The Ventripoint Medical System Plus (VMS+) 3.0 is a software and hardware system that works as an adjunct to ultrasound imaging. It records and analyzes 2D ultrasound images to reconstruct a 3D model of the heart's four chambers, helping clinicians measure heart chamber volumes and ejection fractions. This aids in cardiac assessment by providing detailed and accurate cardiac volume measurements using advanced image analysis techniques.
Intended Use
An adjunct to ultrasound imaging systems intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing, specifically evaluating Left Ventricle, Right Ventricle, Left Atrium, and Right Atrium volumes and ejection fractions.
Technology
Uses a Knowledge-Based Reconstruction (KBR) algorithm requiring placement of anatomical landmarks on 2D ultrasound images to generate a 3D surface model of the four heart chambers and calculate their volumes. Operates on Windows OS with magnetic-based 3D tracking system and software for image acquisition, annotation, analysis, measurement, report generation, and PACS communication.
Performance
Performance testing included biocompatibility, electrical safety, EMC, software verification and validation, and bench performance testing demonstrating substantial equivalence to predicate devices in safety and accuracy. No animal or clinical studies were conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/5/2019
4 months - 2
FDA Approval
10/16/2019
Other devices from Ventripoint Diagnostics, Ltd.
- Ventripoint Medical System Plus (VMS+)2018 • 510K
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