Vscan Air is a pocket-sized, battery-operated ultrasound imaging system designed for use by trained healthcare professionals. It operates wirelessly with a mobile app and provides ultrasound images and measurements across many clinical areas including abdominal, cardiac, obstetrics, musculoskeletal, and vascular applications. The device incorporates AI features to enhance diagnostic accuracy and assist clinicians, such as automatic bladder volume measurement using deep learning, and real-time guidance for cardiac imaging.
Intended Use
Battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners legally authorized or licensed, enabling visualization and measurement of anatomical structures and fluid including blood flow.
Technology
Consists of an app for Android or iOS devices and two wireless probes with curved, linear, and sector transducers. Supports B-mode, color flow Doppler, pulsed wave Doppler, M-mode, combined B+Color Doppler, and harmonic imaging modes. Incorporates AI algorithms for auto bladder volume measurement and compatibility with Caption AI for cardiac ultrasound guidance and estimation of left ventricular ejection fraction.
Performance
Performance testing included verification of AI-based automatic bladder volume measurement on a diverse dataset of 1,817 images from 142 individuals, showing a 92.24% success rate in automatic caliper placement. The device met voluntary standards for medical electrical safety and biocompatibility. No clinical studies were required for equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/14/2025
3 months - 2
FDA Approval
5/1/2025
Other devices from GE Medical Systems Ultrasound and Primary Care Diagnostics
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